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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000747-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Hexal AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP2017 Adalimumab | Experimental | 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. |
|
| Humira ® Adalimumab | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP2017 Adalimumab | Drug |
| ||
| Humira ® Adalimumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 16 only |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 16 |
| Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) |
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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:
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:
Other In-/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center | Birmingham | Alabama | United States | |||
| Alliance Dermatology & MOHS Center, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41709696 | Derived | Betteridge N, Blauvelt A, Edgerton C, Fan J, Guerrieri D, Rose L, Brueckmann I, Wang Q. Comparison of treatment with GP2017 (an adalimumab biosimilar) and reference adalimumab in people with plaque psoriasis: a plain language summary of the ADACCESS trial. Immunotherapy. 2026 Jan;18(1):5-15. doi: 10.1080/1750743X.2026.2624291. Epub 2026 Feb 18. | |
| 39545451 |
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Screening lasted for at least 2 weeks and up to 4 weeks. Main inclusion criteria:
Men or women of at least 18 years
Chronic plaque-type psoriasis ≥ 6 months before randomization
Moderate to severe psoriasis :
No previous exposure to adalimumab
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | GP2017 Adalimumab | Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). |
| FG001 | Humira ® Adalimumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| TREATMENT PERIOD 1 |
|
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|
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). |
| Baseline to Week 16 |
| 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) | At Week 17 only |
| 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) | At Week 35 only |
| PASI 50, PASI75, PASI 90 and PASI100 Response Rates | Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study) | At Week 51 only |
| 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. | At Week 17 only |
| 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 | At Week 35 only |
| 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 | At Week 51 only |
| DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | At Week 17 only |
| DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | At Week 35 only |
| DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | At Week 51 only |
| 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. | At Week 17 only |
| 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. | At Week 51 only |
| 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 | St Louis | Missouri | 63117 | United States |
| The Clinical Research Center, L.L.C. | St 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 | 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 | Košice | Slovakia |
| SANARE s.r.o. Dermatovenerologická ambulancia | Svidník | 08901 | Slovakia |
| SANARE s.r.o. | Svidník | Slovakia |
| Lemke L, Blauvelt A, Bruckmann I, Cohen HP, Fan J, Guerrieri D, Horvat M, Poetzl J, Torella C, Wang Q, von Richter O. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. Expert Opin Biol Ther. 2024 Dec;24(12):1375-1385. doi: 10.1080/14712598.2024.2428299. Epub 2024 Nov 19. |
| 33651341 | Derived | 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. |
Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). |
| FG002 | Humira ® Adalimumab Switched | Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). |
| FG003 | Humira ® Adalimumab Continued | Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period). |
| FG004 | GP2017 Adalimumab Switched | Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). |
| FG005 | GP2017 Adalimumab Continued | GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| TREATMENT PERIOD 2 |
|
|
| EXTENSION PERIOD |
|
|
The Full analysis set (FAS) consists of all randomized patients to whom a study treatment was assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | GP2017 Adalimumab | Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). |
| BG001 | Humira ® Adalimumab | Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16. | Posted | Number | percent of participants | At Week 16 only |
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| Secondary | 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. | The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16. | Posted | Least Squares Mean | Standard Error | percentage change from baseline | Baseline to Week 16 |
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| Secondary | 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). | The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16. | Posted | Least Squares Mean | Standard Error | percentage change from baseline | Baseline to Week 16 |
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| Secondary | 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) | The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16. | Posted | Number | percent of participants | At Week 17 only |
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| Secondary | 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) | Posted | Number | percent of participants | At Week 35 only |
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| Secondary | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study) | Posted | Number | percent of participants | At Week 51 only |
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| Secondary | 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. | The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16. | Posted | Number | percent of participants | At Week 17 only |
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| Secondary | 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 | Posted | Number | percent of participants | At Week 35 only |
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| Secondary | 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 | Posted | Number | percent of participants | At Week 51 only |
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| Secondary | DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16. | Posted | Number | % of patients with DLQI of 0 or 1 | At Week 17 only |
|
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| Secondary | DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | Posted | Number | % of patients with DLQI of 0 or 1 | At Week 35 only |
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| Secondary | DLQI | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) | Posted | Number | % of patients with DLQI of 0 or 1 | At Week 51 only |
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| Secondary | 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. | The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received. | Posted | Number | % patients with at least 1 ADA+ sample | At Week 17 only |
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| Secondary | 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. | The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received. | Posted | Number | % patients with at least 1 ADA+ sample | At Week 51 only |
|
Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Humira ® Adalimumab Switched | Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). | 0 | 63 | 6 | 63 | 40 | 63 |
| EG001 | Humira ® Adalimumab Continued | Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. | 0 | 127 | 10 | 127 | 85 | 127 |
| EG002 | GP2017 Adalimumab Switched | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). | 0 | 63 | 2 | 63 | 47 | 63 |
| EG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. | 1 | 126 | 4 | 126 | 84 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Pneumonia necrotizing | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Abdominall pain | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Renal haematoma | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Gatroenteritis viral | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 19.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 19.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA version 19.0 | Systematic Assessment |
|
none reported
The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Program Medical Director | Sandoz | +49 8024 476 | 0 | biopharma.clinicaltrials@sandoz.com |
| Lack of Efficacy |
|
| Pregnancy |
|
| Death |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Non-compliance with study indication |
|
| Lost to Follow-up |
|
| >=65 years |
|
| Male |
|
| Europe |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|
|
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|
|
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|
| Participants |
|
|
GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). |
| OG003 | GP2017 Adalimumab Continued | GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51. |
|
|