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

Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer 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 Administered Concomitantly With or Without Methotrexate (MTX)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02586246

Enrollment

Registered

2015-10-26

Start date

2011-01-31

Completion date

2013-05-31

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Rheumatoid Arthritis

Keywords

CDP870, Rheumatoid arthritis, Long-term

Brief summary

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.

Interventions

DRUGCDP870

Self-injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study	The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks.
Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12	at Week 12
Percentage of subjects who meet ACR20 criteria at Week 24	at Week 24
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12	at Week 12
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24	at Week 24
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12	at Week 12
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24	at Week 24

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026