At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 353 enrolled
Drug / intervention
Adalimumab - GP2017 +1 morebiological
Likely dose
Adalimumab (GP2017 or US-licensed Humira); specific dose not stated in provided textAI-extracted
Key inclusion· 4
- ✓RA diagnosis ≥6 months prior to screening
- ✓Active disease with DAS28-CRP ≥3.2 at screening
- ✓Elevated inflammatory markers: CRP >5 mg/L or ESR above upper limit of normal
- ✓Inadequate response to methotrexate 10-25 mg/week
Key exclusion· 10
- ✕Prior treatment with adalimumab, anti-TNF therapies, or anti-CD20 agents
- ✕History of inflammatory/autoimmune diseases other than RA (e.g., SLE, mixed connective tissue disease)
- ✕Systemic corticosteroids >7.5 mg/day within 4 weeks prior to baseline
- ✕Active malignancy or lymphoproliferative disease (except treated non-metastatic skin cancers or cervical carcinoma in situ)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Adalimumab - GP2017 and Adalimumab - US licensed Humira for Rheumatoid Arthritis. Completed, enrolled 353 participants across 83 sites in 13 countries.
Detailed Summary
Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCzechia, Germany, Hungary, Italy, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Spain, United Kingdom, United States
CollaboratorsHexal AG
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedApr 2016
Primary CompletionJan 2017
Study CompletionSep 2017
TodayJul 2026
First PostedApr 20, 2016
Enrollment StartMar 31, 2016
Primary CompletionJan 31, 2017
Study CompletionSep 26, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.2 years ago
Interventions
Adalimumab - GP2017biological
Adalimumab - GP2017
Adalimumab - US licensed Humirabiological
Adalimumab - US licensed Humira