Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870

Astellas

Status and phase: Completed; Phase 3

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: CDP870

Study type: Interventional

Funder types: Industry

Identifiers

NCT02586246

275-10-001 (Other Identifier)

1226-CL-A003

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.

Enrollment: 86 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have completed the treatment in the parent clinical studies (NCT00851318 and NCT00850343) up to 52 weeks
• Subjects who are willing to undertake self-injection and provide a written consent

Exclusion criteria

• Patients with serious adverse events
• Patients who are judged by the investigator/subinvestigator to be ineligible to participation in the study for reasons such as uncooperative attitude or nonadherence to study procedures.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

CDP870 group from Study 275-08-002

Experimental group

Description:

Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870

Treatment:

Drug: CDP870

CDP870 group from Study 275-08-004

Experimental group

Description:

Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870

Treatment:

Drug: CDP870