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

Pfizer

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Biological: Rituximab-Pfizer (PF-05280586) x 3 courses

Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses

Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses

Study type

Interventional

Funder types

Industry

Identifiers

NCT01643928

B3281004

ICON 9002/0101

2012-003223-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.