Trials / Completed
CompletedNCT02296775
Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Dr. Reddy's Laboratories Limited · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of DRL\_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be monitored for safety, B cell depletion and recovery, and for the development of immune responses to the administered study drugs
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DRL_RI | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| BIOLOGICAL | Rituxan | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| BIOLOGICAL | MabThera | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-11-01
- Completion
- 2017-10-05
- First posted
- 2014-11-20
- Last updated
- 2020-01-13
- Results posted
- 2020-01-13
Locations
28 sites across 2 countries: India, Ukraine
Source: ClinicalTrials.gov record NCT02296775. Inclusion in this directory is not an endorsement.