NCT01643928

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT01643928

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS

Summary

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.

Eligibility

Inclusion Criteria:

* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.

Exclusion Criteria:

* Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
* Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.

Disease(s) and\or Condition(s)

Rheumatoid Arthritis

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: Rituximab-Pfizer (PF-05280586) x 3 courses
- Description: 1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
- Arm Group Labels: Rituximab-Pfizer
- Type: BIOLOGICAL
- Name: Rituximab-EU+ Rituximab-Pfizer x 2 Courses
- Description: Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
- Arm Group Labels: Rituximab-EU+Rituximab-Pfizer
- Type: BIOLOGICAL
- Name: Rituximab-US + Rituximab-Pfizer x 2 Courses
- Description: Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
- Arm Group Labels: Rituximab-US+Rituximab-Pfizer

Sponsor

Pfizer