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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 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 294 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01682512
The ClinicalTrials.gov registry entry for NCT01682512 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 294 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which BI 695500 is the first listed.
NCT01682512 reports 0 study locations.
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.
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