The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis

UCB

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: CDP6038 (olokizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01533714

RA0089

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 [NCT01463059].

Full description

Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.

Enrollment: 103 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed the RA0083 [NCT01463059] study (Week 12 Visit)
• Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059], and plan to maintain this same dose and route of administration for at least 12 weeks
• Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception

Exclusion criteria

• Have an ongoing SAE from the RA0083 [NCT01463059] study
• Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
• Have evidence of active or latent tuberculosis (TB)
• Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
• Subject has planned surgery during the first 12 weeks of the study
• Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 [NCT01463059] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 [NCT01463059]

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

CDP6038 (olokizumab)

Experimental group

Description:

CDP6038 (olokizumab) 120 mg: subcutaneous injections at q2w (every two weeks). RA0089 is a single arm study, however, analysis will be presented according to the original treatment arms of the parent study NCT01463059 (RA0083).

Treatment:

Biological: CDP6038 (olokizumab)