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NCT02640612 · ClinicalTrials.gov registry record · Phase 3
Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
A Phase 3 study of Arthritis, Rheumatoid, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 430
- Enrollment target
- 20
- Study locations
NCT02640612: Completed Phase 3 study of Arthritis, Rheumatoid, sponsored by Boehringer Ingelheim.
NCT02640612 is a Phase 3 study of Arthritis, Rheumatoid that has completed, run by Boehringer Ingelheim. The registered enrollment target is 430 participants, below the 625-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02640612, a Phase 3 study of Arthritis, Rheumatoid, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 430 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of: * the change from Baseline in DAS28 (ESR) at Week 48 * the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48 * the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48 * the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.
Primary Outcome
The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked "yes" according to the Investigator.
Conditions Studied
Interventions
- DRUG BI 695501
Study Locations (20)
Florida
- Orthopedic Research Institute - Boynton Beach
- Science and Research Institute, Inc. - Jupiter
- San Marcus Research Clinic, Inc. - Miami
- L&C Professional Medical Research Institute - Miami
- Clinical Research of West Florida, Inc. - Tampa
- Lovelace Scientific Resources, Incorporated - Venice
Arizona
- Arizona Arthritis and Rheumatology Research, PLLC - Mesa
- Arizona Arthritis and Rheumatology Research, PLLC - Phoenix
- Arizona Arthritis and Rheumatology Research, PLLC - Phoenix
California
- TriWest Research Associates, LLC - El Cajon
- Advanced Medical Research, LLC - Lakewood
- Inland Rheumatology Clinical Trials, Inc. - Upland
Alabama
- Pinnacle Research Group, LLC - Anniston
Indiana
- Goldpoint Clinical Research, LLC - Indianapolis
Kansas
- Heartland Research Associates, LLC - Wichita
Massachusetts
- Clinical Pharmacology Study Group - Worcester
Michigan
- Arthritis Education and Treatment Center - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2016-01-22 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 3 |
What the finished NCT02640612 record still lists
NCT02640612 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 625-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 1 intervention - of which BI 695501 is the first listed.
NCT02640612 names 20 study sites across 11 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT02640612 about?
NCT02640612 is a clinical study titled "Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis". The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients w...
What is the current status of trial NCT02640612?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 430 participants. The study started on 2016-01-22. Estimated completion is 2017-11-01.
What conditions does trial NCT02640612 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT02640612?
The interventions under investigation include: BI 695501 (DRUG).
Who is sponsoring clinical trial NCT02640612?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02640612 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02640612's enrollment target sits among peer trials
430 13th of 27 higher than 15 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis, Rheumatoid trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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