Trials / Completed
CompletedNCT01274182
GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 312 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GP2013 | 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15) |
| BIOLOGICAL | MabThera | 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15) |
| BIOLOGICAL | Rituxan | 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15) |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2016-01-01
- Completion
- 2016-11-01
- First posted
- 2011-01-11
- Last updated
- 2018-01-24
- Results posted
- 2018-01-24
Locations
57 sites across 14 countries: United States, Argentina, Austria, Belgium, Brazil, Estonia, France, Germany, Hungary, India, Italy, Romania, Spain, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01274182. Inclusion in this directory is not an endorsement.