NCT01526057
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
PHASE2
COMPLETED
NCT01526057
INTERVENTIONAL
A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
Inclusion Criteria:
* Confirmed diagnosis of rheumatoid arthritis
* Meets Class I, II or III of the ACR 1991 Revised Criteria
* RA seropositivity
* Stable dose of methotrexate
* Inadequate response to TNF inhibitors
Exclusion Criteria:
* Any prior treatment with lymphocyte depleting therapies
* History of active TB infection
* Known or screen test positive for specific viruses or indicators of viral infection
Rheumatoid Arthritis
- TREATMENT
-
- Type: BIOLOGICAL
- Name: PF-05280586
- Description: 1000 mg, IV on days 1 and 15
- Arm Group Labels: A - PF-05280586
-
- Type: BIOLOGICAL
- Name: MabThera
- Description: 1000 mg, IV on days 1 and 15
- Arm Group Labels: B - Rituximab EU
-
- Type: BIOLOGICAL
- Name: Rituxan
- Description: 1000 mg, IV on days 1 and 15
- Arm Group Labels: C- Rituximab-US
- Pfizer