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CompletedNCT03783026MOSAICUpdated Feb 21, 2025Results posted

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

A Phase 4 interventional study of Apremilast in Psoriatic Arthritis, sponsored by Amgen. Completed at 36 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Amgen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
123
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.

Read the detailed description

This study consists of 3 phases:

  • Screening Phase - up to 4 weeks

  • Single-arm, Open-label Treatment Phase - Weeks 0 to 48

    • Participants will receive apremilast 30 mg BID (after a 5-day titration period) for the entire duration of this phase.
    • MRI of the most affected hand and whole body MRI (WB-MRI) will be performed at weeks 0, 24, and 48.
    • The hand with the greater inflammatory burden of swollen joints and/or dactylitis will be considered as the most affected hand. If both hands are equally affected, the dominant hand will be designated as the index hand.

  • Observational Follow-up Phase - 4 Weeks

    • All participants who complete the study or discontinue early will participate in the 4-week Post-Treatment Observational Follow-up Phase.
02

Conditions studied

  • Psoriatic Arthritis

Keywords

  • Psoriatic Arthritis
  • CC-10004
  • MRI
  • apremilast
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 123 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Males or females, aged ≥ 18 years at time of consent
  2. For all regions, the local Regulatory Label for treatment with apremilast must be followed.
  3. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
  4. Able to adhere to the study visit schedule and other protocol requirements
  5. Have a documented diagnosis of PsA of ≥ 3 months AND ≤ 5 years in duration, meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at the time of Screening Visit
  6. Have ≥ 3 swollen AND ≥ 3 tender joints, with hand involvement (defined as ≥ 1 swollen joint or dactylitis [each clinically active joint of a dactylitic digit is counted as one joint]).
  7. Have at least 1 active enthesitis site (one of the Spondyloarthritis Research Consortium of Canada [SPARCC] or Leeds Enthesitis Index [LEI] sites)
  8. Must not have been treated previously with a tumor necrosis factor (TNF) blocker or other biologic drug for PsA treatment
  9. Must not have been treated with more than 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
  10. Subjects taking csDMARDs, with the exception of methotrexate (MTX), cyclosporine, or leflunomide (LEF), do not require a washout period. However, they must discontinue the csDMARD treatment at least one day prior to their Baseline Visit (ie, Visit 2, Day 1)
  11. Subjects who have been previously treated with MTX for \< 6 months and who are not on stable doses for at least 3 months will require a 28-day washout prior to the Baseline Visit to participate in the study
  12. Subjects who have been previously treated with LEF will require a 12-week washout prior to the Baseline Visit, or treatment with cholestyramine, per LEF prescribing label (ie, 8 g cholestyramine 3 times daily for 11 days)
  13. Subjects who have been previously treated with cyclosporine will require a 28-day washout prior to the Baseline Visit to participate in the study
  14. If taking MTX (≤ 25 mg/week), continuity of treatment will be allowed if duration of treatment is ≥ 6 months and on a stable dose for at least 3 months prior to the Baseline Visit
  15. If taking oral glucocorticoids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 4 weeks prior to the Baseline Visit
  16. If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 4 weeks prior to Baseline Visit

  17. A female of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of IP, a FCBP who engages in activity in which conception is possible must use one of the approved contraceptive options described below:

    Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

  18. Must be in general good health (except for PsA) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).

Exclusion criteria

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Contraindication to MRI examination including, but not limited to, intracranial metal clips, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators, metal hip replacements, profound claustrophobia or inability to lie in the MRI machine in an appropriate position to obtain quality images, history of hypersensitivity to gadolinium contrast agent
  2. Severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft-Gault equation), which would prevent the use of gadolinium enhancement
  3. History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
  4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  5. Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
  6. Pregnant or breast feeding
  7. Active substance abuse or a history of substance abuse within 6 months prior to screening
  8. History of allergy or hypersensitivity to any component of the IP
  9. History of rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption
  10. History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease)
  11. Active tuberculosis or a history of incompletely treated tuberculosis
  12. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to screening and no new or recurrent infections prior to the Baseline Visit
  13. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
  14. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following Baseline Visit
  15. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia
  16. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease), which confounds the ability to interpret data from the study
  17. Prior treatment with any biologic DMARD
  18. Prior treatment with more than 2 csDMARDs
  19. Use of the following systemic therapy(ies) within 28 days of the Baseline Visit: cyclosporine or other calcineurin inhibitors, glucocorticoids exceeding 10 mg daily prednisone equivalent, as well as mycophenolate.
  20. Use of MTX within 4 weeks of the Baseline Visit, unless subject is on stable doses for at least 3 months and total treatment duration with MTX is ≥ 6 months
  21. Use of LEF within 12 weeks of the Baseline Visit, unless subject has taken cholestyramine, 8 g three times daily 11 days after stopping LEF
  22. Previous treatment with a Janus kinase (JAK) inhibitor (including tyrosine kinase 2 [TYK2] inhibitor)
  23. Prior treatment with apremilast, or participation in a clinical study involving apremilast
  24. Use of intra-articular (IA) glucocorticoid injection within 8 weeks before the Baseline Visit.
  25. Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Apremilast

    Participants will receive apremilast 30 mg twice a day for 48 weeks.

    Drug: Apremilast

Interventions

  • DrugApremilast

    Tablets for oral administration

    Also known as: CC-10004, Otezla®

06

What researchers measure

Primary outcomes

  1. Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis, flexor tenosynovitis, and bone marrow edema were scored from 0 (none/normal) to 3 (severe) at each joint. The total scores for synovitis and tenosynovitis range from 0 to 36 and the total score for BME ranges from 0 to 72 since both proximal and distal regions of each joint were scored. The PsAMRIS composite inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score, and ranges from 0 (normal) to 216 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a mixed-effects model for repeated measures (MMRM) with change from baseline as the dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and week 24

Secondary outcomes

  1. Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis, flexor tenosynovitis, and bone marrow edema were scored from 0 (none/normal) to 3 (severe) at each joint. The total scores for synovitis and tenosynovitis range from 0 to 36 and the total score for BME ranges from 0 to 72 since both proximal and distal regions of each joint were scored. The PsAMRIS composite inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score, and ranges from 0 (normal) to 216 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with change from baseline as the dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and week 48

  2. Change From Baseline in the Composite Score of BME and Synovitis Assessed by PsAMRIS at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis and bone marrow edema were each scored from 0 (none/normal) to 3 (severe) at each joint. The total score for synovitis ranges from 0 to 36 and the total score for BME ranges from 0 to 72 since this is scored at both proximal and distal regions of each joint. The PsAMRIS composite score of BME and synovitis is calculated as: BME score + 2 × synovitis score. The score ranges from 0 (normal) to 144 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline of composite score of BME and synovitis as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  3. Change From Baseline in the PsAMRIS Total Inflammation Score at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand. Synovitis, flexor tenosynovitis, and bone marrow edema were each scored from 0 (none/normal) to 3 (severe) at each joint. Periarticular inflammation was scored 0 (absent) or 1 (present) separately at volar and dorsal aspects of the same 12 joints. The scores for synovitis and tenosynovitis range from 0 to 36, the score for BME is from 0 to 72 and the periarticular inflammation score is from 0 to 24. The PsAMRIS total inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score + 3 × periarticular inflammation, and ranges from 0 (normal) to 288 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with change from baseline score as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  4. Change From Baseline in Bone Marrow Edema Assessed by PsAMRIS at Weeks 24 and 48

    Bone marrow edema (BME) is a buildup of fluid inside the bones. The OMERACT PsAMRIS scoring system assesses BME at the proximal and distal regions of MCP, PIP, and DIP joints of fingers 2 to 5 of the most affected hand. BME is assessed on a scale of 0-3 based on the proportion of bone with edema, compared to the assessed bone volume (articular surface to a depth of 1 cm), judged on all available images; where 0: no edema; 1: 1-33% of bone edema; 2: 34-66% of bone edema; 3: 67-100% of bone edema. The overall score ranges from 0 (none) to 72 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with change from baseline BME score as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  5. Change From Baseline in Synovitis Assessed by PsAMRIS at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis is inflammation of the synovial membrane, connective tissue that lines the inside of the joint. Synovitis was scored from 0 to 3 at MCP, PIP and DIP joints of fingers 2 to 5 (total of 12 joints), where score 0 is normal, and a score of 1 is mild, 2 is moderate, and 3 is severe. The overall synovitis score ranges from 0 (normal) to 36 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline in synovitis score as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  6. Change From Baseline in Tenosynovitis Assessed by PsAMRIS at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Tenosynovitis is inflammation of the protective sheath (synovial membrane) that surrounds tendons. Flexor tenosynovitis was scored from 0 to 3 at MCP, PIP and DIP joints of fingers 2 to 5 (total of 12 joints) where a score of 0 is none; 1: \< 1/2 tendon thickness; 2: ≥ 1/2 and \< 1 tendon thickness; 3: ≥ 1 tendon thickness. The overall tenosynovitis score ranges from 0 (none) to 36 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline in tenosynovitis score as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and Weeks 24 and 48

  7. Change From Baseline in Periarticular Inflammation Assessed by PsAMRIS at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Periarticular inflammation refers to inflammation of the tissues surrounding the joint, including the periosteum and the entheses, but not the tendon sheaths. Periarticular inflammation was scored 0 (absent) or 1 (present) separately at volar and dorsal aspects of the same 12 joint regions as evaluated for synovitis and flexor tenosynovitis. The score for periarticular inflammation ranges from 0 (absent) to 24 (present at all joints). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline in periarticular inflammation as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  8. Change From Baseline in the PsAMRIS Total Damage Score at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses MCP, PIP, and DIP joints of fingers 2 to 5 of the most affected hand. Bone erosion (loss of bone) was assessed at the distal and proximal regions of each joint on a scale of 0 to 10, based on the proportion of eroded bone compared to the assessed bone volume, where 0 is no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. The total erosion score is from 0 (none) to 240 (severe). Bone proliferation (abnormal bone formation in the periarticular region) was scored at each joint as 0 (absent) or 1 (present). The total proliferation score is from 0 to 12 (present at all joints) The total damage score includes the erosion and bone proliferation scores, calculated as: Erosion score + 20 × bone proliferation score, and ranges from 0 (none) to 480 (worst). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  9. Change From Baseline in Bone Erosion Assessed by PsAMRIS at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand. Bone erosion (loss of bone) was assessed at the distal and proximal regions of each joint on a scale of 0-10, based on the proportion of eroded bone compared to the assessed bone volume, judged on all available images: 0: no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. The assessed bone volume is from the articular surface (or its best estimated position if absent) to a depth of 1 cm. The total erosion score ranges from 0 (none) to 240 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  10. Change From Baseline in Bone Proliferation Assessed by PsAMRIS at Weeks 24 and 48

    PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand. Bone proliferation (abnormal bone formation in the periarticular region such as at the entheses and across the joint) was scored at each joint as 0 (absent) or 1 (present). The total proliferation score ranges from 0 (none) to 12 (present at all joints). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  11. Change From Baseline in Swollen Joint Count (SJC) at Weeks 24 and 48

    A total of 76 joints (including the distal interphalangeal joints of the fingers and toes) were examined for swelling.

    Time frame: Baseline and weeks 24 and 48

  12. Change From Baseline in Tender Joint Count (TJC) at Weeks 24 and 48

    A total of 78 joints (including the distal interphalangeal joints of the fingers and toes) were examined for pain or tenderness.

    Time frame: Baseline and weeks 24 and 48

  13. Change From Baseline in the Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) Score at Weeks 24 and 48

    The c-DAPSA is a measure of PsA disease activity, associated with functional and structural outcomes. C-DAPSA is calculated as the sum of the following measures: * Tender joint count 68 (TJC68); * Swollen joint count 66 (SJC66); * Patient global assessment of disease activity measured on a numerical rating scale (NRS) from 0 (not active) to 10 (very active); and * Pain measured on a NRS from 0 (none) to 10 (worst pain imaginable). The c-DAPSA score ranges from 0 to 154, where a higher score indicates greater disease activity. A negative change from baseline indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  14. Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy

    Enthesitis is inflammation of the sites where tendons or ligaments insert into the bone. The SPARCC Enthesitis Index assesses 16 unique sites for tenderness recorded as either present (1) or absent (0) for an overall score range of 0 to 16. A higher count represents greater enthesitis burden. A negative change from baseline indicates improvement. Pre-existing enthesopathy was defined as a baseline SPARCC score greater than 0.

    Time frame: Baseline and weeks 24 and 48

  15. Change From Baseline in the Leeds Enthesitis Index (LEI) at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy

    LEI is a validated tool for the assessment of enthesitis in PsA patients. Tenderness was assessed at 6 sites of tendon insertion (lateral epicondyle, left and right, medial femoral condyle, left and right, and Achilles tendon insertion, left and right). Tenderness was recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A higher count represents a greater enthesitis burden. A negative change from baseline indicates improvement. Pre-existing enthesopathy was defined as a baseline LEI score greater than 0.

    Time frame: Baseline and weeks 24 and 48

  16. Percentage of Participants With Baseline SPARCC Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48

    Enthesitis is inflammation of the sites where tendons or ligaments insert into the bone. The SPARCC Enthesitis Index assesses 16 unique sites for tenderness recorded as either present (1) or absent (0) for an overall score range of 0 to 16. A higher count represents greater enthesitis burden. Resolution of SPARCC enthesitis is defined as achieving a SPARCC index score of 0 for participants with baseline SPARCC enthesitis (SPARCC index score \> 0).

    Time frame: Weeks 24 and 48

  17. Percentage of Participants With Baseline LEI Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48

    LEI is a validated tool for the assessment of enthesitis in PsA patients. Tenderness was assessed at 6 sites of tendon insertion (lateral epicondyle, left and right, medial femoral condyle, left and right, and Achilles tendon insertion, left and right). Tenderness was recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A higher count represents a greater enthesitis burden. Resolution of LEI enthesitis is defined as a LEI score of 0 for participants with baseline LEI enthesitis (LEI score \> 0).

    Time frame: Weeks 24 and 48

  18. Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 24 and 48 in Participants With Pre-existing Dactylitis

    Dactylitis is characterized by the swelling of the entire finger or toe. Dactylitis was assessed using the Leeds Dactylitis Index (LDI). LDI measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score from 0 to 3, where 0 = No Tenderness, 1 = Tender, 2 = Tender and wince, 3 = Tender and withdraw. The dactylitis score is the sum of the individual scores for each digit, where 0 indicates no dactylitis and higher scores represent worse dactylitis. A negative change from baseline indicates improvement. Pre-existing dactylitis is defined as a baseline LDI score greater than 0.

    Time frame: Baseline and weeks 24 and 48

  19. Percentage of Participants With Baseline Dactylitis Whose Dactylitis Count Improved to 0 at Weeks 24 and 48

    Dactylitis is characterized by the swelling of the entire finger or toe. Dactylitis was assessed using the Leeds Dactylitis Index (LDI). LDI measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score from 0 to 3 , where 0 = No Tenderness, 1 = Tender, 2 = Tender and wince, 3 = Tender and withdraw). The LDI score is the sum of the individual scores for each digit, where 0 is no dactylitis and higher scores represent worse dactylitis. Resolution of dactylitis is defined as a LDI score of 0 for participants with dactylitis (LDI score \> 0) at baseline.

    Time frame: Weeks 24 and 48

  20. Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 48

    PASDAS is a measure of disease activity derived from the following variables: * Physician and patient global assessment of disease activity (assessed on a 0-10 NRS, then multiplied by 10) * 68 tender joint count * 66 swollen joint count * Short Form-36 Questionnaire (SF-36) physical component summary score (general health status on a scale from 0-100) * Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20) * Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6) * C-reactive protein (CRP) level (mg/L) The composite score is a weighted index that ranges from 0 to 10, with worse disease activity represented by higher scores. A negative change from baseline indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  21. Change From Baseline in the Evaluator's Global Assessment of Disease Activity at Weeks 24 and 48

    The Evaluator's Global Assessment of Disease Activity evaluates how active a participant's PsA was on the day of the assessment. Disease activity was assessed on a 0 to 10 numeric rating scale (NRS) where 0 represents "no arthritis activity," and 10 represents "extreme active arthritis". A negative change from baseline indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  22. Change From Baseline in the Patient's Global Assessment of Disease Activity at Weeks 24 and 48

    The Patient's Global Assessment is an assessment of how active a participant's arthritis was on average during the past week. The score ranges from 0 to 10 based on a numerical rating scale, where 0 represents 'Very Well' and 10 represents 'Very Poor'. A negative change from baseline indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  23. Change From Baseline in the Subject's Assessment of Pain at Weeks 24 and 48

    The Subject's Assessment of Pain is an assessment of how much pain a participant had on average during the past week due to psoriatic arthritis. The score ranges from 0-10 based on a numerical rating scale, where 0 represents 'No Pain' and 10 represents 'Pain As Bad As You Can Imagine'. A negative change from baseline indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  24. Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 24 and 48

    The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  25. Change From Baseline in Whole Body MRI (WB-MRI) Peripheral Enthesitis Inflammation Index at Weeks 24 and 48

    Enthesitis was assessed by whole body MRI according to the OMERACT MRI Whole-Body Score for Inflammation in Peripheral Joints and Entheses in Inflammatory Arthritis (MRI-WIPE) scoring system. Thirty-three entheseal sites were assessed for soft tissue inflammation (STI) and 34 sites for osteitis, including the shoulder, pelvis, knees and feet, each on a scale from 0 (none) to 3 (severe). The Total Peripheral Enthesitis Inflammation score is calculated by adding up all the enthesitis (STI and osteitis) scores and ranges from 0 to 201, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. WB-MRI endpoints were analyzed using a MMRM including change from baseline as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  26. Change From Baseline in the WB-MRI Peripheral Joints Inflammation Index at Weeks 24 and 48

    Joint inflammation was assessed by whole body MRI according to the OMERACT MRI-WIPE scoring system. Eighty-three peripheral joints were assessed for synovitis and 96 sites for osteitis at the shoulder, hands, pelvis, knees and feet on a semiquantitative scale from 0 (none) to 3 (severe). The Peripheral Joint Inflammation score is calculated by adding up all the joint (synovitis and osteitis) scores and ranges from 0 to 537, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. WB MRI endpoints were analyzed using a MMRM including change from baseline as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  27. Change From Baseline in the WB-MRI Total Peripheral Inflammation Index at Weeks 24 and 48

    Inflammation in joints (arthritis) and at entheses (enthesitis) were assessed separately for soft tissues (synovitis at joints, soft tissue inflammation at entheses) and bone (osteitis) by whole body MRI according to the OMERACT MRI-WIPE scoring system. Each entheseal and joint was scored on a scale from 0 (none) to 3 (severe). The total peripheral inflammation index is the sum of peripheral enthesitis and peripheral joints inflammation index scores, and ranges from 0 to 738, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. WB MRI endpoints were analyzed using a MMRM including change from baseline as dependent variable; baseline value, scanner type and time as independent variables.

    Time frame: Baseline and weeks 24 and 48

  28. Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 24 and 48

    BASDAI is a composite score based on a self-administered survey of six questions with each answered on a 0 to 10 NRS. The 6 questions assess the five major symptoms relevant to spondyloarthropathies: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the 5 symptoms equal weighting, the mean of the two scores relating to morning stiffness (questions 5 and 6) is taken. The final BASDAI score is calculated as the mean of the 5 items. The BASDAI score ranges from 0 to 10, with higher scores reflecting greater disease activity. A negative change from baseline indicates improvement. BASDAI was analyzed in participants deemed to have PsA spondylitis by the investigator and with BASDAI item 2 score ≥ 4 at baseline).

    Time frame: Baseline and weeks 24 and 48

  29. Change From Baseline in the Psoriatic Arthritis Impact of Disease 12 Domain Questionnaire (PsAID-12) at Weeks 24 and 48

    The PsAID consists of 12 physical and psychological domains: pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment and/or shame, social life, and depression. Each domain is scored on a NRS rom 0 to 10. The final score is derived as a weighted sum of each domain score, divided by 20, and has a range from 0 (best status) to 10 (worst status). A negative change from baseline indicates improvement.

    Time frame: Baseline and weeks 24 and 48

  30. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    A TEAE is any adverse event (AE) that began or worsened on or after the first dose of apremilast and no later than 28 days after the last dose. A serious adverse event is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event. For each AE, the Investigator assessed the severity/intensity of the event as mild, moderate, or severe (symptoms causing severe discomfort/pain, interference with daily activities, and requiring medical, surgical or drug therapy). The Investigator also assessed whether each event was suspected to be related to study drug based on whether there was evidence to suggest a causal relationship.

    Time frame: From first dose of study drug up to 28 days after last dose; up to 52 weeks.

07

Results

Posted Dec 19, 2022

Participant flow

This study was conducted at 43 centers in Austria, Belgium, Canada, Denmark, Germany, Italy, Russia, Spain, Switzerland, United Kingdom, and the United States.

Treatment Phase
Participant flow — Treatment Phase
MilestoneApremilast
Started123
Received apremilast122
Completed80
Not completed43
Withdrew: Adverse event15
Withdrew: Lack of efficacy11
Withdrew: Withdrawal by subject6
Withdrew: Lost to follow-up2
Withdrew: Protocol deviation8
Withdrew: Did not receive treatment1
Observational Follow-up Phase
Participant flow — Observational Follow-up Phase
MilestoneApremilast
Started111
Completed108
Not completed3
Withdrew: Lost to follow-up3

Outcome measures

PrimaryChange From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis, flexor tenosynovitis, and bone marrow edema were scored from 0 (none/normal) to 3 (severe) at each joint. The total scores for synovitis and tenosynovitis range from 0 to 36 and the total score for BME ranges from 0 to 72 since both proximal and distal regions of each joint were scored. The PsAMRIS composite inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score, and ranges from 0 (normal) to 216 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a mixed-effects model for repeated measures (MMRM) with change from baseline as the dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24
score on a scaleApremilast
Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24-2.32 (-4.73 to 0.09)
SecondaryChange From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis, flexor tenosynovitis, and bone marrow edema were scored from 0 (none/normal) to 3 (severe) at each joint. The total scores for synovitis and tenosynovitis range from 0 to 36 and the total score for BME ranges from 0 to 72 since both proximal and distal regions of each joint were scored. The PsAMRIS composite inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score, and ranges from 0 (normal) to 216 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with change from baseline as the dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and week 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 48
score on a scaleApremilast
Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 48-2.91 (-5.45 to -0.37)
SecondaryChange From Baseline in the Composite Score of BME and Synovitis Assessed by PsAMRIS at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis and bone marrow edema were each scored from 0 (none/normal) to 3 (severe) at each joint. The total score for synovitis ranges from 0 to 36 and the total score for BME ranges from 0 to 72 since this is scored at both proximal and distal regions of each joint. The PsAMRIS composite score of BME and synovitis is calculated as: BME score + 2 × synovitis score. The score ranges from 0 (normal) to 144 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline of composite score of BME and synovitis as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Composite Score of BME and Synovitis Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 24-1.19 (-2.89 to 0.50)
Week 48-1.54 (-3.53 to 0.46)
SecondaryChange From Baseline in the PsAMRIS Total Inflammation Score at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand. Synovitis, flexor tenosynovitis, and bone marrow edema were each scored from 0 (none/normal) to 3 (severe) at each joint. Periarticular inflammation was scored 0 (absent) or 1 (present) separately at volar and dorsal aspects of the same 12 joints. The scores for synovitis and tenosynovitis range from 0 to 36, the score for BME is from 0 to 72 and the periarticular inflammation score is from 0 to 24. The PsAMRIS total inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score + 3 × periarticular inflammation, and ranges from 0 (normal) to 288 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with change from baseline score as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in the PsAMRIS Total Inflammation Score at Weeks 24 and 48
score on a scaleApremilast
Week 24-3.62 (-7.11 to -0.12)
Week 48-4.35 (-8.14 to -0.56)
SecondaryChange From Baseline in Bone Marrow Edema Assessed by PsAMRIS at Weeks 24 and 48

Bone marrow edema (BME) is a buildup of fluid inside the bones. The OMERACT PsAMRIS scoring system assesses BME at the proximal and distal regions of MCP, PIP, and DIP joints of fingers 2 to 5 of the most affected hand. BME is assessed on a scale of 0-3 based on the proportion of bone with edema, compared to the assessed bone volume (articular surface to a depth of 1 cm), judged on all available images; where 0: no edema; 1: 1-33% of bone edema; 2: 34-66% of bone edema; 3: 67-100% of bone edema. The overall score ranges from 0 (none) to 72 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with change from baseline BME score as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Bone Marrow Edema Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.22 (-0.83 to 0.38)
Week 48-0.39 (-1.14 to 0.37)
SecondaryChange From Baseline in Synovitis Assessed by PsAMRIS at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis is inflammation of the synovial membrane, connective tissue that lines the inside of the joint. Synovitis was scored from 0 to 3 at MCP, PIP and DIP joints of fingers 2 to 5 (total of 12 joints), where score 0 is normal, and a score of 1 is mild, 2 is moderate, and 3 is severe. The overall synovitis score ranges from 0 (normal) to 36 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline in synovitis score as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Synovitis Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.47 (-1.11 to 0.16)
Week 48-0.65 (-1.39 to 0.10)
SecondaryChange From Baseline in Tenosynovitis Assessed by PsAMRIS at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Tenosynovitis is inflammation of the protective sheath (synovial membrane) that surrounds tendons. Flexor tenosynovitis was scored from 0 to 3 at MCP, PIP and DIP joints of fingers 2 to 5 (total of 12 joints) where a score of 0 is none; 1: \< 1/2 tendon thickness; 2: ≥ 1/2 and \< 1 tendon thickness; 3: ≥ 1 tendon thickness. The overall tenosynovitis score ranges from 0 (none) to 36 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline in tenosynovitis score as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and Weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Tenosynovitis Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.64 (-1.10 to -0.19)
Week 48-0.78 (-1.15 to -0.40)
SecondaryChange From Baseline in Periarticular Inflammation Assessed by PsAMRIS at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Periarticular inflammation refers to inflammation of the tissues surrounding the joint, including the periosteum and the entheses, but not the tendon sheaths. Periarticular inflammation was scored 0 (absent) or 1 (present) separately at volar and dorsal aspects of the same 12 joint regions as evaluated for synovitis and flexor tenosynovitis. The score for periarticular inflammation ranges from 0 (absent) to 24 (present at all joints). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM including change from baseline in periarticular inflammation as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Periarticular Inflammation Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.49 (-0.90 to -0.07)
Week 48-0.59 (-1.04 to -0.13)
SecondaryChange From Baseline in the PsAMRIS Total Damage Score at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses MCP, PIP, and DIP joints of fingers 2 to 5 of the most affected hand. Bone erosion (loss of bone) was assessed at the distal and proximal regions of each joint on a scale of 0 to 10, based on the proportion of eroded bone compared to the assessed bone volume, where 0 is no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. The total erosion score is from 0 (none) to 240 (severe). Bone proliferation (abnormal bone formation in the periarticular region) was scored at each joint as 0 (absent) or 1 (present). The total proliferation score is from 0 to 12 (present at all joints) The total damage score includes the erosion and bone proliferation scores, calculated as: Erosion score + 20 × bone proliferation score, and ranges from 0 (none) to 480 (worst). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in the PsAMRIS Total Damage Score at Weeks 24 and 48
score on a scaleApremilast
Week 240.22 (-1.10 to 0.53)
Week 480.50 (-0.38 to 1.38)
SecondaryChange From Baseline in Bone Erosion Assessed by PsAMRIS at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand. Bone erosion (loss of bone) was assessed at the distal and proximal regions of each joint on a scale of 0-10, based on the proportion of eroded bone compared to the assessed bone volume, judged on all available images: 0: no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. The assessed bone volume is from the articular surface (or its best estimated position if absent) to a depth of 1 cm. The total erosion score ranges from 0 (none) to 240 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Bone Erosion Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.01 (-0.06 to 0.05)
Week 480.03 (-0.04 to 0.10)
SecondaryChange From Baseline in Bone Proliferation Assessed by PsAMRIS at Weeks 24 and 48

PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand. Bone proliferation (abnormal bone formation in the periarticular region such as at the entheses and across the joint) was scored at each joint as 0 (absent) or 1 (present). The total proliferation score ranges from 0 (none) to 12 (present at all joints). A negative change from baseline indicates improvement. This endpoint was analyzed using a MMRM with baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Bone Proliferation Assessed by PsAMRIS at Weeks 24 and 48
score on a scaleApremilast
Week 240.01 (-0.01 to 0.03)
Week 480.02 (-0.02 to 0.07)
SecondaryChange From Baseline in Swollen Joint Count (SJC) at Weeks 24 and 48

A total of 76 joints (including the distal interphalangeal joints of the fingers and toes) were examined for swelling.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · joints
Change From Baseline in Swollen Joint Count (SJC) at Weeks 24 and 48
jointsApremilast
Week 24-5.8 ± 7.11
Week 48-6.3 ± 8.02
SecondaryChange From Baseline in Tender Joint Count (TJC) at Weeks 24 and 48

A total of 78 joints (including the distal interphalangeal joints of the fingers and toes) were examined for pain or tenderness.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · joints
Change From Baseline in Tender Joint Count (TJC) at Weeks 24 and 48
jointsApremilast
Week 24-7.9 ± 9.39
Week 48-8.4 ± 10.97
SecondaryChange From Baseline in the Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) Score at Weeks 24 and 48

The c-DAPSA is a measure of PsA disease activity, associated with functional and structural outcomes. C-DAPSA is calculated as the sum of the following measures: * Tender joint count 68 (TJC68); * Swollen joint count 66 (SJC66); * Patient global assessment of disease activity measured on a numerical rating scale (NRS) from 0 (not active) to 10 (very active); and * Pain measured on a NRS from 0 (none) to 10 (worst pain imaginable). The c-DAPSA score ranges from 0 to 154, where a higher score indicates greater disease activity. A negative change from baseline indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) Score at Weeks 24 and 48
score on a scaleApremilast
Week 24-15.3 ± 14.04
Week 48-17.2 ± 16.46
SecondaryChange From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy

Enthesitis is inflammation of the sites where tendons or ligaments insert into the bone. The SPARCC Enthesitis Index assesses 16 unique sites for tenderness recorded as either present (1) or absent (0) for an overall score range of 0 to 16. A higher count represents greater enthesitis burden. A negative change from baseline indicates improvement. Pre-existing enthesopathy was defined as a baseline SPARCC score greater than 0.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy
score on a scaleApremilast
Week 24-1.8 ± 2.26
Week 48-2.3 ± 2.00
SecondaryChange From Baseline in the Leeds Enthesitis Index (LEI) at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy

LEI is a validated tool for the assessment of enthesitis in PsA patients. Tenderness was assessed at 6 sites of tendon insertion (lateral epicondyle, left and right, medial femoral condyle, left and right, and Achilles tendon insertion, left and right). Tenderness was recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A higher count represents a greater enthesitis burden. A negative change from baseline indicates improvement. Pre-existing enthesopathy was defined as a baseline LEI score greater than 0.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Leeds Enthesitis Index (LEI) at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy
score on a scaleApremilast
Week 24-1.3 ± 1.38
Week 48-1.5 ± 1.19
SecondaryPercentage of Participants With Baseline SPARCC Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48

Enthesitis is inflammation of the sites where tendons or ligaments insert into the bone. The SPARCC Enthesitis Index assesses 16 unique sites for tenderness recorded as either present (1) or absent (0) for an overall score range of 0 to 16. A higher count represents greater enthesitis burden. Resolution of SPARCC enthesitis is defined as achieving a SPARCC index score of 0 for participants with baseline SPARCC enthesitis (SPARCC index score \> 0).

Time frame:
Weeks 24 and 48
Reported as:
Number · percentage of participants
Percentage of Participants With Baseline SPARCC Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48
percentage of participantsApremilast
Week 2446.9 (36.61 to 57.34)
Week 4857.0 (45.33 to 68.06)
SecondaryPercentage of Participants With Baseline LEI Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48

LEI is a validated tool for the assessment of enthesitis in PsA patients. Tenderness was assessed at 6 sites of tendon insertion (lateral epicondyle, left and right, medial femoral condyle, left and right, and Achilles tendon insertion, left and right). Tenderness was recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A higher count represents a greater enthesitis burden. Resolution of LEI enthesitis is defined as a LEI score of 0 for participants with baseline LEI enthesitis (LEI score \> 0).

Time frame:
Weeks 24 and 48
Reported as:
Number · percentage of participants
Percentage of Participants With Baseline LEI Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48
percentage of participantsApremilast
Week 2456.4 (44.70 to 67.61)
Week 4862.3 (48.96 to 74.39)
SecondaryChange From Baseline in Leeds Dactylitis Index (LDI) at Weeks 24 and 48 in Participants With Pre-existing Dactylitis

Dactylitis is characterized by the swelling of the entire finger or toe. Dactylitis was assessed using the Leeds Dactylitis Index (LDI). LDI measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score from 0 to 3, where 0 = No Tenderness, 1 = Tender, 2 = Tender and wince, 3 = Tender and withdraw. The dactylitis score is the sum of the individual scores for each digit, where 0 indicates no dactylitis and higher scores represent worse dactylitis. A negative change from baseline indicates improvement. Pre-existing dactylitis is defined as a baseline LDI score greater than 0.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 24 and 48 in Participants With Pre-existing Dactylitis
score on a scaleApremilast
Week 24-34.38 ± 21.322
Week 48-38.71 ± 21.793
SecondaryPercentage of Participants With Baseline Dactylitis Whose Dactylitis Count Improved to 0 at Weeks 24 and 48

Dactylitis is characterized by the swelling of the entire finger or toe. Dactylitis was assessed using the Leeds Dactylitis Index (LDI). LDI measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score from 0 to 3 , where 0 = No Tenderness, 1 = Tender, 2 = Tender and wince, 3 = Tender and withdraw). The LDI score is the sum of the individual scores for each digit, where 0 is no dactylitis and higher scores represent worse dactylitis. Resolution of dactylitis is defined as a LDI score of 0 for participants with dactylitis (LDI score \> 0) at baseline.

Time frame:
Weeks 24 and 48
Reported as:
Number · percentage of participants
Percentage of Participants With Baseline Dactylitis Whose Dactylitis Count Improved to 0 at Weeks 24 and 48
percentage of participantsApremilast
Week 2489.2 (74.58 to 96.97)
Week 4893.3 (77.93 to 99.18)
SecondaryChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 48

PASDAS is a measure of disease activity derived from the following variables: * Physician and patient global assessment of disease activity (assessed on a 0-10 NRS, then multiplied by 10) * 68 tender joint count * 66 swollen joint count * Short Form-36 Questionnaire (SF-36) physical component summary score (general health status on a scale from 0-100) * Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20) * Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6) * C-reactive protein (CRP) level (mg/L) The composite score is a weighted index that ranges from 0 to 10, with worse disease activity represented by higher scores. A negative change from baseline indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 48
score on a scaleApremilast
Week 24-1.752 ± 1.3002
Week 48-1.833 ± 1.4146
SecondaryChange From Baseline in the Evaluator's Global Assessment of Disease Activity at Weeks 24 and 48

The Evaluator's Global Assessment of Disease Activity evaluates how active a participant's PsA was on the day of the assessment. Disease activity was assessed on a 0 to 10 numeric rating scale (NRS) where 0 represents "no arthritis activity," and 10 represents "extreme active arthritis". A negative change from baseline indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Evaluator's Global Assessment of Disease Activity at Weeks 24 and 48
score on a scaleApremilast
Week 24-2.7 ± 1.99
Week 48-2.8 ± 2.11
SecondaryChange From Baseline in the Patient's Global Assessment of Disease Activity at Weeks 24 and 48

The Patient's Global Assessment is an assessment of how active a participant's arthritis was on average during the past week. The score ranges from 0 to 10 based on a numerical rating scale, where 0 represents 'Very Well' and 10 represents 'Very Poor'. A negative change from baseline indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Patient's Global Assessment of Disease Activity at Weeks 24 and 48
score on a scaleApremilast
Week 24-1.3 ± 2.09
Week 48-1.6 ± 2.24
SecondaryChange From Baseline in the Subject's Assessment of Pain at Weeks 24 and 48

The Subject's Assessment of Pain is an assessment of how much pain a participant had on average during the past week due to psoriatic arthritis. The score ranges from 0-10 based on a numerical rating scale, where 0 represents 'No Pain' and 10 represents 'Pain As Bad As You Can Imagine'. A negative change from baseline indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Subject's Assessment of Pain at Weeks 24 and 48
score on a scaleApremilast
Week 24-1.4 ± 2.10
Week 48-2.0 ± 2.13
SecondaryChange From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 24 and 48

The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.293 ± 0.4162
Week 48-0.383 ± 0.4654
SecondaryChange From Baseline in Whole Body MRI (WB-MRI) Peripheral Enthesitis Inflammation Index at Weeks 24 and 48

Enthesitis was assessed by whole body MRI according to the OMERACT MRI Whole-Body Score for Inflammation in Peripheral Joints and Entheses in Inflammatory Arthritis (MRI-WIPE) scoring system. Thirty-three entheseal sites were assessed for soft tissue inflammation (STI) and 34 sites for osteitis, including the shoulder, pelvis, knees and feet, each on a scale from 0 (none) to 3 (severe). The Total Peripheral Enthesitis Inflammation score is calculated by adding up all the enthesitis (STI and osteitis) scores and ranges from 0 to 201, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. WB-MRI endpoints were analyzed using a MMRM including change from baseline as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in Whole Body MRI (WB-MRI) Peripheral Enthesitis Inflammation Index at Weeks 24 and 48
score on a scaleApremilast
Week 24-0.17 (-0.65 to 0.31)
Week 48-0.52 (-1.01 to -0.02)
SecondaryChange From Baseline in the WB-MRI Peripheral Joints Inflammation Index at Weeks 24 and 48

Joint inflammation was assessed by whole body MRI according to the OMERACT MRI-WIPE scoring system. Eighty-three peripheral joints were assessed for synovitis and 96 sites for osteitis at the shoulder, hands, pelvis, knees and feet on a semiquantitative scale from 0 (none) to 3 (severe). The Peripheral Joint Inflammation score is calculated by adding up all the joint (synovitis and osteitis) scores and ranges from 0 to 537, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. WB MRI endpoints were analyzed using a MMRM including change from baseline as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in the WB-MRI Peripheral Joints Inflammation Index at Weeks 24 and 48
score on a scaleApremilast
Week 24-3.38 (-5.10 to -1.66)
Week 48-3.58 (-5.66 to -1.51)
SecondaryChange From Baseline in the WB-MRI Total Peripheral Inflammation Index at Weeks 24 and 48

Inflammation in joints (arthritis) and at entheses (enthesitis) were assessed separately for soft tissues (synovitis at joints, soft tissue inflammation at entheses) and bone (osteitis) by whole body MRI according to the OMERACT MRI-WIPE scoring system. Each entheseal and joint was scored on a scale from 0 (none) to 3 (severe). The total peripheral inflammation index is the sum of peripheral enthesitis and peripheral joints inflammation index scores, and ranges from 0 to 738, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. WB MRI endpoints were analyzed using a MMRM including change from baseline as dependent variable; baseline value, scanner type and time as independent variables.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Least squares mean · score on a scale
Change From Baseline in the WB-MRI Total Peripheral Inflammation Index at Weeks 24 and 48
score on a scaleApremilast
Week 24-3.49 (-5.46 to -1.52)
Week 48-4.06 (-6.39 to -1.72)
SecondaryChange From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 24 and 48

BASDAI is a composite score based on a self-administered survey of six questions with each answered on a 0 to 10 NRS. The 6 questions assess the five major symptoms relevant to spondyloarthropathies: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the 5 symptoms equal weighting, the mean of the two scores relating to morning stiffness (questions 5 and 6) is taken. The final BASDAI score is calculated as the mean of the 5 items. The BASDAI score ranges from 0 to 10, with higher scores reflecting greater disease activity. A negative change from baseline indicates improvement. BASDAI was analyzed in participants deemed to have PsA spondylitis by the investigator and with BASDAI item 2 score ≥ 4 at baseline).

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 24 and 48
score on a scaleApremilast
Week 24-1.94 ± 1.935
Week 48-2.01 ± 2.246
SecondaryChange From Baseline in the Psoriatic Arthritis Impact of Disease 12 Domain Questionnaire (PsAID-12) at Weeks 24 and 48

The PsAID consists of 12 physical and psychological domains: pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment and/or shame, social life, and depression. Each domain is scored on a NRS rom 0 to 10. The final score is derived as a weighted sum of each domain score, divided by 20, and has a range from 0 (best status) to 10 (worst status). A negative change from baseline indicates improvement.

Time frame:
Baseline and weeks 24 and 48
Reported as:
Mean · score on a scale
Change From Baseline in the Psoriatic Arthritis Impact of Disease 12 Domain Questionnaire (PsAID-12) at Weeks 24 and 48
score on a scaleApremilast
Week 24-1.352 ± 1.8441
Week 48-1.612 ± 1.6613
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

A TEAE is any adverse event (AE) that began or worsened on or after the first dose of apremilast and no later than 28 days after the last dose. A serious adverse event is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event. For each AE, the Investigator assessed the severity/intensity of the event as mild, moderate, or severe (symptoms causing severe discomfort/pain, interference with daily activities, and requiring medical, surgical or drug therapy). The Investigator also assessed whether each event was suspected to be related to study drug based on whether there was evidence to suggest a causal relationship.

Time frame:
From first dose of study drug up to 28 days after last dose; up to 52 weeks.
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsApremilast
Any treatment-emergent adverse event (TEAE)95
Any drug-related TEAE60
Any severe TEAE6
Any serious TEAE6
Any serious drug-related TEAE0
Any TEAE leading to study drug interruption12
Any TEAE leading to study drug withdrawal15
Any TEAE leading to death0

Adverse events

Collected over From first dose of study drug up to 28 days after last dose; up to 52 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Apremilast0/123 (0%)6/122 (4.9%)63/122 (51.6%)
Most frequent serious events
Most frequent serious events
EventApremilast
Angina pectorisCardiac disorders1/122
Non-cardiac chest painGeneral disorders1/122
COVID-19 pneumoniaInfections and infestations1/122
PneumoniaInfections and infestations1/122
Acetabulum fractureInjury, poisoning and procedural complications1/122
FallInjury, poisoning and procedural complications1/122
Pelvic fractureInjury, poisoning and procedural complications1/122
AsthmaRespiratory, thoracic and mediastinal disorders1/122
Most frequent other events
Most frequent other events
EventApremilast
DiarrhoeaGastrointestinal disorders41/122
NauseaGastrointestinal disorders15/122
HeadacheNervous system disorders13/122
NasopharyngitisInfections and infestations9/122
DyspepsiaGastrointestinal disorders8/122
PsoriasisSkin and subcutaneous tissue disorders7/122

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)Apremilast
Mean46.6 ± 12.89
Age, Customized
Age, Customized(Participants)Apremilast
< 65 years111
≥ 65 years12
Sex: Female, Male
Sex: Female, Male(Participants)Apremilast
Female68
Male55
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Apremilast
Hispanic or Latino8
Not Hispanic or Latino111
Unknown or Not Reported4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Apremilast
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American0
White117
More than one race0
Unknown or Not Reported2
Duration of Psoriatic Arthritis
Duration of Psoriatic Arthritis(years)Apremilast
Mean1.9 ± 1.66
Synovitis Score Assessed by PsAMRIS
Synovitis Score Assessed by PsAMRIS(score on a scale)Apremilast
Mean6.13 ± 5.121
Tenosynovitis Score Assessed by PsAMRIS
Tenosynovitis Score Assessed by PsAMRIS(score on a scale)Apremilast
Mean1.70 ± 3.268

8 further baseline measures are reported on the registry.

08

Study locations

36 sites
  • The Doctors of Saint John's Medical Group
    Santa Monica, California 90404, United States
  • Inland Rheumatology Clinical Trials Inc
    Upland, California 91786, United States
  • Malcom Randall VA Medical Center
    Gainesville, Florida 32610, United States
  • Integral Rheumatology and Immunology Specialists
    Plantation, Florida 33324, United States
  • NYU Langone Medical Center
    New York, New York 10003, United States
  • Austin Regional Clinic
    Austin, Texas 78731, United States
  • Swedish Medical Center
    Seattle, Washington 98104, United States
  • Medizinische Universitat Wien
    Vienna, 1090, Austria
  • UZ Leuven
    Leuven, 3000, Belgium
  • University of Calgary - Cumming School of Medicine
    Calgary, Alberta T2N 4N1, Canada
  • Alberta Rheumatology
    Edmonton, Alberta T5M 0H4, Canada
  • Ottawa Hospital Research Institute
    Ottawa, Ontario K1H 7W9, Canada
  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
    Quebec, G1V 3M7, Canada
  • Aalborg Universitetshospital
    Aalborg, 9000, Denmark
  • Frederiksberg Hospital
    Frederiksberg, 2000, Denmark
  • Copenhagen University Hospital Rigshospitalet
    Glostrup, 2600, Denmark
  • Universitaetsklinikum Bonn
    Bonn, 53127, Germany
  • Universitaetsklinikum Duesseldorf
    Duesseldorf, 40225, Germany
  • Johann Wolfgang Goethe University Hospital
    Frankfurt am Main, 60590, Germany
  • Universitaetsklinikum Tuebingen
    Tuebingen, 72076, Germany
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Ospedale Vittorio Emanuele
    Catania, 95123, Italy
  • Azienda Ospedaliera Regionale San Carlo
    Potenza/Matera, 85100, Italy
  • Udmurt Republic Republican Clinical Diagnostic Center
    Izhevsk, 426009, Russian Federation
  • Research Institute of Rheumatology named after V.A.Nasonova
    Moscow, 115522, Russian Federation
  • LLC Medical Center Zdorovaya Semiya
    Novosibirsk, 630061, Russian Federation
  • Mechnikov North-Western State Medical University
    Saint-Petersburg, 191015, Russian Federation
  • Regional Clinical Hospital No 1 - Tyumen
    Tyumen, 625032, Russian Federation
  • Hospital Virgen de Macarena
    Sevilla, Andalucía 41009, Spain
  • Hospital Santa Creu I Sant Pau
    Barcelona, 08041, Spain
  • Hospital La Paz
    Madrid, 28046, Spain
  • Kantonsspital Aarau - KSA
    Aarau, 5001, Switzerland
  • Hopital Universitaire Genevois - Beau-Sejour Hospital
    Geneve, 1206, Switzerland
  • Kantonsspital St Gallen
    Sankt Gallen, 9007, Switzerland
  • NHS Lothian, Western General Hospital
    Edinburgh, EH16 4TJ, United Kingdom
  • The Leeds Teaching Hospitals NHS Trust - Chapel Allerton Hospital
    Leeds, LS7 4SA, United Kingdom
  • Southampton University Hospitals NHS Trust
    Southampton, SO16 6YD, United Kingdom
09

References and documents

Publications

  • Ostergaard M, Boesen M, Maksymowych WP, Lambert RG, Bubb MR, Kubassova O, Valenzuela G, Reddy J, Colgan S, Klyachkin Y, Deignan C, Zhou Z, Amouzadeh H, Mease PJ. Effect of apremilast on hand and whole-body MRI assessments of inflammation in patients with psoriatic arthritis (MOSAIC): a phase 4, multicentre, single-arm, open-label study. Lancet Rheumatol. 2025 Feb;7(2):e118-e126. doi: 10.1016/S2665-9913(24)00232-7. Epub 2024 Oct 30. PubMed 39488216 ↗

Study documents

  • Study protocol · May 4, 2020
  • Statistical analysis plan · May 12, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03783026
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Dec 20, 2018
Start date
Feb 6, 2019
Primary completion
Oct 26, 2021
Completion
May 11, 2022
Results posted
Dec 19, 2022
Last update
Feb 21, 2025

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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