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NCT02137226 · ClinicalTrials.gov registry record · Phase 3
BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
A Phase 3 study of Arthritis, Rheumatoid, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 645
- Enrollment target
- 20
- Study locations
NCT02137226: Completed Phase 3 study of Arthritis, Rheumatoid, sponsored by Boehringer Ingelheim.
NCT02137226 is a Phase 3 study of Arthritis, Rheumatoid that has completed, run by Boehringer Ingelheim. The registered enrollment target is 645 participants, roughly in line with the 617-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02137226, a Phase 3 study of Arthritis, Rheumatoid, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 645 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®. Secondary Objectives: The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.
Primary Outcome
The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (DAS)), Physici
Conditions Studied
Interventions
- DRUG BI 695501
- DRUG US-licensed Humira®
Study Locations (20)
California
- TriWest Research Associates, LLC - El Cajon
- Advanced Medical Research, LLC - La Palma
- ProHealth Partners - Long Beach
- The Permanente Medical Group - Santa Clara
- Inland Rheumatology Clinical Trials, Inc. - Upland
- Medvin Clinical Research - Whittier
Florida
- Orthopedic Research Institute - Boynton Beach
- Clinical Research of West Florida, Inc. - Clearwater
- Universal Clinical Research - Coral Gables
- Science and Research Institute, Inc. - Jupiter
- San Marcus Research Clinic, Inc. - Miami
- L&C Professional Medical Research Institute - Miami
Arizona
- Arizona Arthritis and Rheumatology Research, PLLC - Glendale
- Arizona Arthritis and Rheumatology Research, PLLC - Mesa
- Arizona Arthritis and Rheumatology Research, PLLC - Phoenix
- Arizona Arthritis and Rheumatology Research, PLLC - Phoenix
Alabama
- Pinnacle Research Group, LLC - Anniston
- Rheumatology Associates - Birmingham
- Achieve Clinical Research, LLC - Birmingham
Colorado
- Alpine Clinical Research Center - Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 645 participants |
| Start Date | 2015-01-26 |
| Est. Completion | 2016-10-18 |
| Phase | Phase 3 |
What the finished NCT02137226 record still lists
NCT02137226 is an interventional study that assigns participants to a tested intervention. The registered 645 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 617-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target.
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 2 interventions - of which BI 695501 is the first listed.
NCT02137226 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02137226 about?
NCT02137226 is a clinical study titled "BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis". Primary Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR2...
What is the current status of trial NCT02137226?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 645 participants. The study started on 2015-01-26. Estimated completion is 2016-10-18.
What conditions does trial NCT02137226 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT02137226?
The interventions under investigation include: BI 695501 (DRUG), US-licensed Humira® (DRUG).
Who is sponsoring clinical trial NCT02137226?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02137226 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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645 7th of 27 higher than 21 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
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