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NCT01955733 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
NCT01955733: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01955733 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 91 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955733, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
Study Summary
The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1.
Primary Outcome
This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study \[1301.4\] and prior to the last date of trial medication + 180 days \[inclusive\]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.
Interventions
- DRUG BI 695500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2013-05-31 |
| Est. Completion | 2016-11-07 |
| Phase | Phase 3 |
Why NCT01955733 stopped before completion
NCT01955733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which BI 695500 is the first listed.
NCT01955733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01955733 about?
NCT01955733 is a clinical study titled "Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis". The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1.
What is the current status of trial NCT01955733?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2013-05-31. Estimated completion is 2016-11-07.
What interventions are being tested in trial NCT01955733?
The interventions under investigation include: BI 695500 (DRUG).
Who is sponsoring clinical trial NCT01955733?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01955733's enrollment target sits among peer trials
91 1724th of 2000 higher than 277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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