Trials / Terminated
TerminatedNCT01682512
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 294 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 695500 | |
| DRUG | BI 695500 | |
| DRUG | Rituxan® | |
| DRUG | Rituxan® | |
| DRUG | MabThera® |
Timeline
- Start date
- 2012-09-05
- Primary completion
- 2015-11-17
- Completion
- 2016-10-12
- First posted
- 2012-09-11
- Last updated
- 2018-01-30
- Results posted
- 2018-01-30
Locations
110 sites across 17 countries: United States, Argentina, Belgium, Bulgaria, Canada, Chile, Germany, Greece, Hungary, Ireland, Mexico, Netherlands, Poland, Portugal, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01682512. Inclusion in this directory is not an endorsement.