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CompletedNCT02016105ADACCESSUpdated May 30, 2017Results posted

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

A Phase 3 interventional study of GP2017 Adalimumab and Humira ® Adalimumab in Plaque Type Psoriasis, sponsored by Sandoz. Completed at 79 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Sandoz · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
465
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Read the detailed description

The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

02

Conditions studied

  • Plaque Type Psoriasis

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Keywords

  • plaque type psoriasis
  • equivalent efficacy
  • safety and immunogenicity
  • GP2017
  • Humira®
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 465 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) 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

  • Men or women at least 18 years of age at time of screening
  • Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization

  • Moderate to severe psoriasis as defined at baseline by:

    • PASI score of 12 or greater
    • Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
    • Body Surface Area affected by plaque-type psoriasis of 10% or greater
  • Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion criteria

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque-type
  • Drug-induced psoriasis
  • Ongoing use of prohibited psoriasis treatments
  • Previous exposure to adalimumab
  • Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab

Other In-/Exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
465 participants (actual)

Study arms

  • Experimental
    GP2017 Adalimumab

    Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

    Drug: GP2017 Adalimumab

  • Active comparator
    Humira ® Adalimumab

    Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

    Drug: Humira ® Adalimumab

Interventions

  • DrugGP2017 Adalimumab
  • DrugHumira ® Adalimumab
06

What researchers measure

Primary outcomes

  1. PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab

    The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.

    Time frame: At Week 16 only

Secondary outcomes

  1. Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)

    The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.

    Time frame: Baseline to Week 16

  2. Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)

    The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).

    Time frame: Baseline to Week 16

  3. PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates

    Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)

    Time frame: At Week 17 only

  4. PASI 50, PASI75, PASI 90 and PASI100 Response Rates

    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)

    Time frame: At Week 35 only

  5. PASI 50, PASI75, PASI 90 and PASI100 Response Rates

    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)

    Time frame: At Week 51 only

  6. IGA Response Rate

    Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.

    Time frame: At Week 17 only

  7. IGA Response Rate

    Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

    Time frame: At Week 35 only

  8. IGA Response Rate

    Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

    Time frame: At Week 51 only

  9. DLQI

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

    Time frame: At Week 17 only

  10. DLQI

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

    Time frame: At Week 35 only

  11. DLQI

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

    Time frame: At Week 51 only

  12. ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17

    Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17. Patients with ADA positive results at baseline were excluded from subsequent results.

    Time frame: At Week 17 only

  13. ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51

    Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51. Patients with ADA positive results at baseline were excluded from subsequent results.

    Time frame: At Week 51 only

07

Results

Posted Apr 7, 2017
Limitations and caveats
none reported

Participant flow

661 patients were screened. 465 patients were randomized 1:1 into Treatment Period 1 and stratified by region (US/EU), body weight (\<90/≥90 kg) and prior systemic therapy (no/any). In Treatment Period 2 patients were re-randomized 2:1 to either continue originally assigned treatment or switch treatment and were stratified by region only.

TREATMENT PERIOD 1
Participant flow — TREATMENT PERIOD 1
MilestoneGP2017 AdalimumabHumira ® AdalimumabHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
Started2312340000
Completed2012010000
Not completed30330000
Withdrew: Protocol violation280000
Withdrew: Physician decision020000
Withdrew: Lack of efficacy420000
Withdrew: Pregnancy010000
Withdrew: Adverse event350000
Withdrew: Withdrawal by subject15110000
Withdrew: Lost to follow-up640000
TREATMENT PERIOD 2
Participant flow — TREATMENT PERIOD 2
MilestoneGP2017 AdalimumabHumira ® AdalimumabHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
Started006312763126
Completed005711659112
Not completed00611414
Withdrew: Non compliance study medication000001
Withdrew: Lack of efficacy002632
Withdrew: Pregnancy000001
Withdrew: Death000001
Withdrew: Adverse event000401
Withdrew: Withdrawal by subject003117
Withdrew: Lost to follow-up001001
EXTENSION PERIOD
Participant flow — EXTENSION PERIOD
MilestoneGP2017 AdalimumabHumira ® AdalimumabHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
Started005210956106
Completed004710450100
Not completed005566
Withdrew: New therapy for study indication000011
Withdrew: Lack of efficacy001311
Withdrew: Adverse event002010
Withdrew: Withdrawal by subject002222
Withdrew: Non-compliance with study indication000010
Withdrew: Lost to follow-up000002

Outcome measures

PrimaryPASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab

The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.

Time frame:
At Week 16 only
Reported as:
Number · percent of participants
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
percent of participantsGP2017 AdalimumabHumira ® Adalimumab
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab66.865.0
Statistical analysis
  • GP2017 Adalimumab vs Humira ® Adalimumab · Risk difference (rd): 1.8 · 95% CI -7.46 to 11.15
SecondaryMean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)

The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.

Time frame:
Baseline to Week 16
Reported as:
Least squares mean · percentage change from baseline
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
percentage change from baselineGP2017 AdalimumabHumira ® Adalimumab
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)-60.7 ± 1.54-61.5 ± 1.55
Statistical analysis
  • GP2017 Adalimumab vs Humira ® Adalimumab · Ls means difference: 0.8 · 95% CI -3.15 to 4.84
SecondaryMean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)

The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).

Time frame:
Baseline to Week 16
Reported as:
Least squares mean · percentage change from baseline
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
percentage change from baselineGP2017 AdalimumabHumira ® Adalimumab
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)-59.7 ± 1.5960.8 ± 1.61
Statistical analysis
  • GP2017 Adalimumab vs Humira ® Adalimumab · Ls means difference: 1.2 · 95% CI -2.78 to 5.08
SecondaryPASI 50, PASI 75, PASI 90 and PASI 100 Response Rates

Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)

Time frame:
At Week 17 only
Reported as:
Number · percent of participants
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
percent of participantsGP2017 AdalimumabHumira ® Adalimumab
% of patients achieving PASI50 at Week 1793.292.8
% of patients achieving PASI75 at Week 1771.468.6
% of patients achieving PASI90 at Week 1751.644.8
% of patients achieving PASI100 at Week 1721.916.5
SecondaryPASI 50, PASI75, PASI 90 and PASI100 Response Rates

Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)

Time frame:
At Week 35 only
Reported as:
Number · percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
percent of participantsHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
% of patients achieving PASI50 at Week 3595.996.494.196.1
% of patients achieving PASI75 at Week 3573.573.670.674.5
% of patients achieving PASI90 at Week 3553.152.762.761.8
% of patients achieving PASI100 at Week 3528.630.935.333.3
SecondaryPASI 50, PASI75, PASI 90 and PASI100 Response Rates

Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)

Time frame:
At Week 51 only
Reported as:
Number · percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
percent of participantsHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
% of patients achieving PASI50 at Week 5195.393.987.595.9
% of patients achieving PASI75 at Week 5176.779.675.084.5
% of patients achieving PASI90 at Week 5148.851.060.462.9
% of patients achieving PASI100 at Week 5125.629.631.335.1
SecondaryIGA Response Rate

Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.

Time frame:
At Week 17 only
Reported as:
Number · percent of participants
IGA Response Rate
percent of participantsGP2017 AdalimumabHumira ® Adalimumab
IGA Response Rate53.653.6
SecondaryIGA Response Rate

Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

Time frame:
At Week 35 only
Reported as:
Number · percent of participants
IGA Response Rate
percent of participantsHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
IGA Response Rate59.258.258.858.8
SecondaryIGA Response Rate

Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

Time frame:
At Week 51 only
Reported as:
Number · percent of participants
IGA Response Rate
percent of participantsHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
IGA Response Rate46.555.158.359.8
SecondaryDLQI

Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

Time frame:
At Week 17 only
Reported as:
Number · % of patients with DLQI of 0 or 1
DLQI
% of patients with DLQI of 0 or 1GP2017 AdalimumabHumira ® Adalimumab
DLQI50.548.4
SecondaryDLQI

Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

Time frame:
At Week 35 only
Reported as:
Number · % of patients with DLQI of 0 or 1
DLQI
% of patients with DLQI of 0 or 1Humira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
DLQI49.054.552.955.9
SecondaryDLQI

Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

Time frame:
At Week 51 only
Reported as:
Number · % of patients with DLQI of 0 or 1
DLQI
% of patients with DLQI of 0 or 1Humira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
DLQI48.855.654.259.8
SecondaryADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17

Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17. Patients with ADA positive results at baseline were excluded from subsequent results.

Time frame:
At Week 17 only
Reported as:
Number · % patients with at least 1 ADA+ sample
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17
% patients with at least 1 ADA+ sampleGP2017 AdalimumabHumira ® Adalimumab
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 1736.834.1
SecondaryADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51

Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51. Patients with ADA positive results at baseline were excluded from subsequent results.

Time frame:
At Week 51 only
Reported as:
Number · % patients with at least 1 ADA+ sample
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51
% patients with at least 1 ADA+ sampleHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 5139.345.146.735.8

Adverse events

Collected over Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Humira ® Adalimumab Switched0/63 (0%)6/63 (9.5%)40/63 (63.5%)
Humira ® Adalimumab Continued0/127 (0%)10/127 (7.9%)85/127 (66.9%)
GP2017 Adalimumab Switched0/63 (0%)2/63 (3.2%)47/63 (74.6%)
GP2017 Adalimumab Continued1/126 (0.8%)4/126 (3.2%)84/126 (66.7%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
PneumoniaInfections and infestations2/631/1270/630/126
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/631/1271/631/126
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/630/1271/630/126
Non-cardiac chest painGeneral disorders1/630/1270/630/126
PyrexiaGeneral disorders1/630/1270/630/126
SwellingGeneral disorders1/630/1270/630/126
Schizoaffective disorderPsychiatric disorders0/630/1271/630/126
Renal colicRenal and urinary disorders1/630/1270/630/126
Joint effusionMusculoskeletal and connective tissue disorders1/630/1270/630/126
PyelonephritisInfections and infestations0/630/1270/631/126
Most frequent other events
Showing 10 of 54
Most frequent other events
EventHumira ® Adalimumab SwitchedHumira ® Adalimumab ContinuedGP2017 Adalimumab SwitchedGP2017 Adalimumab Continued
NasopharyngitisInfections and infestations7/6316/1278/6312/126
HeadacheNervous system disorders7/637/1272/6313/126
Upper respiratory tract infectionInfections and infestations5/6311/1273/6312/126
ArthralgiaMusculoskeletal and connective tissue disorders3/633/1276/635/126
SinusitisInfections and infestations2/637/1273/6311/126
Injection site erythemaGeneral disorders0/633/1275/636/126
HypertensionVascular disorders3/6310/1270/632/126
Back painMusculoskeletal and connective tissue disorders1/635/1274/635/126
FatigueGeneral disorders1/637/1274/633/126
CoughRespiratory, thoracic and mediastinal disorders4/635/1271/632/126

Baseline characteristics

The Full analysis set (FAS) consists of all randomized patients to whom a study treatment was assigned.

Age, Categorical
Age, Categorical(Participants)GP2017 AdalimumabHumira ® AdalimumabTotal
<=18 years000
Between 18 and 65 years205208413
>=65 years262652
Age, Continuous
Age, Continuous(years)GP2017 AdalimumabHumira ® AdalimumabTotal
Mean45.6 ± 14.1646.9 ± 14.0946.3 ± 14.12
Sex: Female, Male
Sex: Female, Male(Participants)GP2017 AdalimumabHumira ® AdalimumabTotal
Female8992181
Male142142284
Region of Enrollment
Region of Enrollment(participants)GP2017 AdalimumabHumira ® AdalimumabTotal
United States188190378
Europe434487
08

Study locations

79 sites
  • Total Skin & Beauty Dermatology Center
    Birmingham, Alabama, United States
  • Alliance Dermatology & MOHS Center, PC
    Phoenix, Arizona 85032, United States
  • Burke Pharmaceutical Research
    Hot Springs, Arkansas, United States
  • Anaheim Clinical Trials
    Anaheim, California, United States
  • Bakersfield Dermatology and Skin Cancer Medical Group
    Bakersfield, California, United States
  • Wallace Medical Group
    Beverly Hills, California 90211, United States
  • California Dermatology & Clinical Research Institute
    Encinitas, California 92024, United States
  • Dr. Howard Sofen
    Los Angeles, California, United States
  • Southern California Permanente Medical Group
    Los Angeles, California, United States
  • Palmtree Clinical Research
    Rancho Mirage, California 92270, United States
  • Medical Center For Clinical Research
    San Diego, California, United States
  • Therapeutics Clinical Research
    San Diego, California, United States
  • Clinical Science Institute
    Santa Monica, California 90404, United States
  • Ventura Clinical Trials
    Ventura, California 93003, United States
  • Horizons Clinical Research Center, LLC
    Denver, Colorado 80220, United States
  • Savin Dermatology Center, P.C.
    New Haven, Connecticut, United States
  • Florida Academic Dermatology Center
    Coral Gables, Florida, United States
  • Florida Medical Center & Research Inc
    Miami, Florida, United States
  • Renstar Medical Research
    Ocala, Florida 34471, United States
  • Psoriasis Treatment Center of South Florida
    Pembroke Pines, Florida 33028, United States
  • McIlwain Medical Group, PA
    Tampa, Florida 33613, United States
  • MedPhase, Inc.
    Newnan, Georgia 30263, United States
  • Pharmaceutical Research Organization
    Rigby, Idaho, United States
  • Dundee Derm.
    West Dundee, Illinois, United States
  • Dawes Fretzin Clinical Research Group, LLC
    Indianapolis, Indiana 46256, United States
  • The Dermatology Center, PSC
    New Albany, Indiana 47150, United States
  • The Indiana Clinical Trials Center
    Plainfield, Indiana, United States
  • Dermatology Specialists Research, LLC
    Louisville, Kentucky 40202, United States
  • DermResearch, PLLC
    Louisville, Kentucky, United States
  • Pedia Research, LLC
    Owensboro, Kentucky, United States
  • Medical Development Centers, LLC
    Baton Rouge, Louisiana 70808, United States
  • Dermat. & Adv. Aesthetics
    Lake Charles, Louisiana, United States
  • Clinical Trials of America, Inc.
    Monroe, Louisiana, United States
  • Bay State Clinical Trials, Inc.
    Watertown, Massachusetts, United States
  • Great Lakes Research Group, Inc.
    Bay City, Michigan 48706, United States
  • Somerset Skin Centre
    Troy, Michigan, United States
  • Associated Skin Care Specs
    Fridley, Minnesota, United States
  • MediSearch Clinical Trials
    Saint Joseph, Missouri, United States
  • Central Dermatology
    Saint Louis, Missouri 63117, United States
  • The Clinical Research Center, L.L.C.
    Saint Louis, Missouri, United States
  • J. Woodson Dermatology & Associates
    Henderson, Nevada, United States
  • Las Vegas Skin and Cancer Clinic
    Las Vegas, Nevada 89128, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Buffalo Medical Group, P.C.
    Buffalo, New York, United States
  • Forest Hills Dermatology Group
    Forest Hills, New York 11375, United States
  • New York University Medical
    Lake Success, New York 11041, United States
  • DermResearch Center of New York
    Stony Brook, New York, United States
  • PMG Research of Charlotte, LLC
    Charlotte, North Carolina, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • Wilmington Dermatology Center
    Wilmington, North Carolina 28403, United States
  • PMG Research of Winston-Salem, LLC
    Winston-Salem, North Carolina, United States
  • Ohio State University Clinical Trials Management Office
    Columbus, Ohio, United States
  • Lynn Health Science Institute
    Oklahoma City, Oklahoma 73112, United States
  • Corvallis Clinic PC
    Corvallis, Oregon 97330, United States
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
  • Oregon Medical Research Center, P.C.
    Portland, Oregon 97223, United States
  • University of Pittsburgh Medical Center Health System
    Pittsburgh, Pennsylvania 15213, United States
  • Clinical Partners, LLC
    Johnston, Rhode Island, United States
  • Radiant Research, Inc.
    Greer, South Carolina, United States
  • Health Concepts
    Rapid City, South Dakota, United States
  • PMG Research of Bristol, LLC
    Bristol, Tennessee 37620, United States
  • Austin Dermatology Associates
    Austin, Texas 78705, United States
  • Menter Dermatology Research Institute
    Dallas, Texas, United States
  • Modern Research Associates
    Dallas, Texas, United States
  • Stephen Miller MD
    San Antonio, Texas 78249, United States
  • Center for Clinical Studies
    Webster, Texas, United States
  • Advanced Research Institute
    Ogden, Utah, United States
  • Premier Clinical Research
    Spokane, Washington, United States
  • Mountain State Clinical Research
    Clarksburg, West Virginia, United States
  • UMHAT Dr. Georgi Stranski, EAD
    Pleven, Bulgaria
  • Center for Skin and Venereal Diseases EOOD Sofia
    Sofia, Bulgaria
  • UMHAT "Alexandrovska", EAD
    Sofia, Bulgaria
  • Diagnostic-consulting center 3-Varna EOOD
    Varna, Bulgaria
  • Hopital de l'Archet 2
    Nice Cedex 3, France
  • Hôpital Charles Nicolle
    Rouen, France
  • Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc
    Kosice-Saca, Slovakia
  • Pedi-Derma s.r.o., Dermatovenerologicka ambulancia
    Kosice, Slovakia
  • SANARE s.r.o.
    Svidnik, Slovakia
  • SANARE s.r.o. Dermatovenerologická ambulancia
    Svidník, 08901, Slovakia
09

References and documents

Publications

  • Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2. PubMed 33651341 ↗

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02016105
Lead sponsor
Sandoz
Collaborators
Hexal AG
Responsible party
Sponsor
First posted
Dec 19, 2013
Start date
Dec 2013
Primary completion
Jul 2015
Completion
Feb 2016
Results posted
Apr 7, 2017
Last update
May 30, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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