A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New to Conventional, Targeted and Biological DMARDs

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• Spondylitis 623
• Spondylarthritis 597
• Axial Spondyloarthritis 203

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 351 is above the median of 202 across 256 observational studies indexed under Spondylitis.

Lead sponsor

Janssen-Cilag S.p.A. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Study population

Groups and cohorts

• SpA with DMARDs

  Participants with first diagnosis or confirmed diagnosis of Spondyloarthritis (SpA) and naïve to conventional, targeted or biological Disease modifying anti-rheumatic drugs (DMARDs) will be observed in order to describe SpA characteristics and pattern of clinical presentation.

Primary outcomes

1. Diagnostic Delay

   Time of diagnostic delay, defined as the time in months from first symptoms to diagnosis, and reasons for this delay.

   Time frame: Baseline (Month 0)

2. Prevalence of Axial Versus Peripheral Manifestations According to Assessment of Spondyloarthritis Classification (ASAS) Criteria

   The ASAS criteria distinguish axial from peripheral SpA. ASAS criteria for axial SpA: chronic back pain (\>=3 months) with onset at age \<45 years, and include imaging and clinical arm. Imaging criteria: must have sacroiliitis visible on either pelvic radiograph (representing the Ankylosing Spondylitis subgroup) or active inflammation detected by Magnetic Resonance Imagining (MRI) of the sacroiliac joints, and at least one other feature of SpA. Clinical criteria: should be Human Leukocyte Antigen (HLA) B27 positive and have at least two other SpA associated features. ASAS criteria for peripheral manifestations: must have arthritis, dactylitis or enthesitis in combination with either at least one of psoriasis, inflammatory bowel disease, uveitis, preceding genitourinary or gastro intestinal infection, HLA B27 positivity or sacroiliitis, or with two or more of arthritis, dactylitis, enthesitis, inflammatory back pain (at any time in the participant's history) or a family history of SpA.

   Time frame: Up to visit 5 (Approximately 24 months)

3. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by ASDAS Score

   The ASDAS is composite score based on the calculation of 5 disease activities: 4 are participant's reported outcomes (back pain, duration of morning stiffness, participant global and peripheral pain/swelling) and one serologic inflammation marker (C-reactive protein \[CRP\]). The score is the sum of the 5 items with different specified weights, with a minimum of 0 and no upper limit. Thus this index can reflect both long term disease activity and acute phase status. There are 2 cut-offs in score to show: a) the 4 states of disease activity: inactive disease (less than \[\<\] 1.3), moderate disease activity (1.3-2.1), high disease activity (2.1-3.5) and very high disease activity (greater than \[\>\] 3.5). b) effectiveness of the treatment, two validated cut-offs were developed: a change of 1.1-2.0 (clinically important improvement) and a change \>2.0 (major improvement).

   Time frame: Up to visit 5 (Approximately 24 months)

4. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by BASMI Score

   The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an index for measuring the mobility of the axial skeleton in participant affected by ankylosing spondylitis (AS). This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall distance, lumbar flexion, intermalleoar distance and cervical rotation. Individual scores are averaged to give a final score between 0 and 10. A higher BASMI10 score reflects more severe spinal mobility limitation.

   Time frame: Up to visit 5 (Approximately 24 months)

5. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by DAS28 Score

   The Disease Activity and functional status assessment (DAS) 28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0 = no disease activity to 100 = maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 less than or equal to (\<=) 3.2 or a change from Baseline less than (\<) -1.2. EULAR Moderate response: DAS28 greater than (\>) 3.2 to \<= 5.1 or a change from Baseline \< -0.6 to greater than or equal to (\>=) -1.2.

   Time frame: Up to visit 5 (Approximately 24 month)

6. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by Disease Activity Index for PsA (DAPSA) Score

   The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on visual analog scale (VAS) (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Joints assessed include the distal interphalangeal (DIP), proximal interphalangeal (PIP), and metacarpophalangeal (MCP) joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and PIP joints of the feet. CRP level in milligrams per deciliters (mg/dL). Cutoff values for low and high disease activity are \<= 18.5 and \>= 45.1 points, 25 respectively, and for remission is \<= 3.3 points.

   Time frame: Up to visit 5 (Approximately 24 months)

7. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by MDA

   Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the participant and physician. The goal of the development of this instrument is to "treat to target" to achieve disease remission or low disease activity state. For a participant to achieve MDA, 5 of the following 7 criteria must be met: Tender joint count =\<1; Swollen joint count =\<1; Psoriasis Area and Severity Index (PASI) =\<1 or Body surface area (BSA) =\<3; Participant pain VAS =\<15; Participant global activity VAS =\<20; HAQ =\<0.5; Tender enthesial points =\<1.

   Time frame: Up to visit 5 (Approximately 24 months)

8. Drug Retention for cDMARDs, tDMARDs and bDMARDs

   Drug Retention is defined as the time in months in which participants maintain the same therapy.

   Time frame: Up to visit 5 (Approximately 24 months)

9. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

   An adverse event is any untoward medical occurrence in a clinical study that does not necessarily have a causal relationship with the investigational drug under study.

   Time frame: Up to visit 5 (Approximately 24 months)

Secondary outcomes

1. Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP)

   The ASDAS is an index for measuring disease activity in participant affected by ankylosing spondylitis. The ASDAS-CRP is derived from back pain, duration of morning stiffness, general well being, C-reactive protein (CRP) and peripheral joint pain/swelling. Total score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of CRP. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity (\> 3.5).

   Time frame: Up to visit 5 (Approximately 24 month)

2. Bath Ankylosing Spondylitis Metrology Index (BASMI) 10

   The BASMI is an index for measuring the mobility of the axial skeleton in participant affected by ankylosing spondylitis. This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall distance, lumbar flexion, intermalleoar distance and cervical rotation. Individual scores are averaged to give a final score between 0 and 10. A higher BASMI10 score reflects more severe spinal mobility limitation.

   Time frame: Up to visit 5 (Approximately 24 month)

3. Disease Activity Score (DAS) 28

   The DAS 28 is a composite score derived from the following 4 measures. The index considers four parameters to obtain the total score: Count the number of swollen joints (out of the 28); Count the number of tender joints (out of the 28); C-reactive protein (CRP) expressed in milligram per milliLitre (mg/mL); Participant's Global Assessment of disease activity.

   Time frame: Up to visit 5 (Approximately 24 month)

4. Disease Activity Index for Psoriatic Arthritis (DAPSA)

   The DAPSA is a score used to measure disease activity in participant affected by psoriatic arthritis. It comprises: 68 tender and 66 swollen joints count; Participant global assessment of health; Participant pain Visual analogue scale (VAS); C-reactive protein level (milligram per deciLiter \[mg/dl\]).

   Time frame: Up to visit 5 (Approximately 24 month)

5. Minimal Disease Activity (MDA)

   The MDA is a state of disease activity deemed a useful target of treatment by both the participant and physician. For a participant to achieve MDA, 5 of the following 7 criteria must be met: Tender joint count less than or equal to (\<=) 1; Swollen joint count \<= 1; PASI \<= 1 or BSA \<= 3; Participant pain VAS \<= 15; Participant global activity VAS \<= 20; Health Assessment Questionnaire (HAQ) \<= 0.5; Tender enthesial points \<= 1.

   Time frame: Up to visit 5 (Approximately 24 month)

6. Body Surface Area (BSA)

   The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" which equates to approximately 1 % of total body surface area. The disease severity will be classified using the following categories: mild (BSA less than \[\<\] 3 %), moderate (BSA from 3% to 10%), and severe (BSA more than \[\>\] 10 %).

   Time frame: Up to visit 5 (Approximately 24 month)

7. Bath Ankylosing Spondylitis Functional Index (BASFI)

   The BASFI is used to define and monitor physical functioning in participants with ankylosing spondylitis. BASFI is composed by 10 items. Score range is 0-10, with 0 (easy), reflecting no functional impairments, and 10 (impossible), reflecting maximal impairment.

   Time frame: Up to visit 5 (Approximately 24 month)

8. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

   The BASDAI is used to measure participant reported disease activity in participants with ankylosing spondylitis. A numeric response scale (0-10) with "none" and "very severe" is used to answer. The final score ranges from 0 (no disease activity) to 10 (maximal disease activity). A cut off of 4 is used to define active disease.

   Time frame: Up to visit 5 (Approximately 24 month)

9. Health Assessment Questionnaire - Disability Index (HAQ-DI)

   The HAQ-DI is used to assess the physical functioning of the participant.The participant is required to indicate the degree of difficulty they have experienced, in each 8 items of the questionnaire, in the past week, in a 4 point scale. The responses in each functional area are: 0 = able to do with no difficulty; 1 = able to do with some difficulty; 2 = able to do with much difficulty; and 3 = unable to do. The 10 individual subscale scores are averaged to give a summary score. The range of the final calculates summary score is 0-3 where lower scores are indicative of better functioning and higher score reflects worse function. HAQ-DI scores of 0 to 1 generally represent mild to moderate functional difficulty, 1 to 2 represent moderate to severe functional difficulty, and 2 to 3 indicate severe to very severe limitations of physical function or disability.

   Time frame: Up to visit 5 (Approximately 24 month)

10. Work Productivity and Activity Impairment Questionnaire (WPAI-SHP)

    The WPAI is a validated, self administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI-SHP outcomes are expressed as impairment percentages; with higher numbers indicate greater impairment and less productivity, that is, worse outcomes.

    Time frame: Up to visit 5 (Approximately 24 month)

Other outcomes

1. Number of Participants With 66/68 Swollen/Tender Joints Count

   Participant's swollen and tender joints 66/68 will be evaluated at each visit.

   Time frame: Up to 5 visits (approximately 24 months)

2. Physician Global Assessment of Participant (PhGA) Joints and Skin

   The PhGA, joint and skin, will be manually filled in by physician and will be documented using a VAS scale. PhGA VAS for pain ranges from "Quite" (0 millimeter \[mm\]) to "Very Severe" (100 mm); VAS for joint ranges from "No Inflammation" (0 mm) to "Very Severe" (100 mm); VAS for skin ranges from "Clear" (0 mm) to "Very Severe" (100 mm).

   Time frame: Up to 5 visits (approximately 24 months)

3. Number of Participants With Enthesitis

   The Maastricht Ankylosing Spondylitis Entheses Score (MASES) is a feasible index using to investigate the enthesitis. 13 specific and sensitive sites were examined and a dichotomous 0/1 score is used to value the grading of tenderness.

   Time frame: Up to 5 visits (approximately 24 months)

4. Number of Participants With Nail Lesions

   Number of participants with count of nail lesions will be presented.

   Time frame: Up to 5 visits (approximately 24 months)

5. Number of Participants With Dactylitis

   The total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.

   Time frame: Up to 5 visits (approximately 24 months)

6. Number of Participants With Fibromyalgia

   Fibromyalgia is evaluated by American College of Rheumatology (ACR) 2010 criteria.

   Time frame: Up to 5 visits (approximately 24 months)

7. Number of Participants With Pain by Visual Analog Scale (VAS)

   The pain VAS is a self-administered assessment used to measure the average pain during the past week. The score ranges between 0 "No pain" to 0 "The Worst Possible Pain".

   Time frame: Up to 5 visits (approximately 24 months)

8. Number of Participants With Sleep Quality by VAS

   The Sleep Quality VAS questionnaire provides a measurement of quality of sleep experienced by the participant. This subjective method attempts to measure qualitative aspects of sleep and is easily administered. The score ranges from between 0 "Very Good" to 100 "Very Bad".

   Time frame: Up to 5 visits (approximately 24 months)

9. Participant's Global Assessment (PtGA) by VAS

   The PtGA by VAS measuring the overall way the disease affects the participants at a point in time. The score will be recorded as a single vertical mark on a 100 millimeter (mm) visual analogic scale (VAS), with 0 representing the lowest level of disease activity and 100 representing the highest.

   Time frame: Up to 5 visits (approximately 24 months)