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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02640612
The ClinicalTrials.gov registry entry for NCT02640612 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 625-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (31% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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