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NCT01682512 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 294
- Enrollment target
NCT01682512: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01682512 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 294 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01682512, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 294 participants
- Enrollment target
Study Summary
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.
Primary Outcome
The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.70\*ln(ESR) + 0.014\*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS \[score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)\]. DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined a
Interventions
- DRUG BI 695500
- DRUG Rituxan®
- DRUG MabThera®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2012-09-05 |
| Est. Completion | 2016-10-12 |
| Phase | Phase 3 |
Why NCT01682512 stopped before completion
NCT01682512 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which BI 695500 is the first listed.
NCT01682512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01682512 about?
NCT01682512 is a clinical study titled "Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis". The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Act...
What is the current status of trial NCT01682512?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 294 participants. The study started on 2012-09-05. Estimated completion is 2016-10-12.
What interventions are being tested in trial NCT01682512?
The interventions under investigation include: BI 695500 (DRUG), Rituxan® (DRUG), MabThera® (DRUG).
Who is sponsoring clinical trial NCT01682512?
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 NCT01682512's enrollment target sits among peer trials
294 1166th of 2000 higher than 835 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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