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

NCT ID: NCT02586246

Last Updated: 2015-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Active Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CDP870 group from Study 275-08-002

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

Group Type EXPERIMENTAL

CDP870

Intervention Type DRUG

Self-injection

CDP870 group from Study 275-08-004

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

Group Type EXPERIMENTAL

CDP870

Intervention Type DRUG

Self-injection

Interventions

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CDP870

Self-injection

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Aichi, , Japan

Site Status

Fukuoka, , Japan

Site Status

Gunma, , Japan

Site Status

Hiroshima, , Japan

Site Status

Hokkaido, , Japan

Site Status

Hyōgo, , Japan

Site Status

Kagawa, , Japan

Site Status

Kagoshima, , Japan

Site Status

Kanagawa, , Japan

Site Status

Kumamoto, , Japan

Site Status

Nagasaki, , Japan

Site Status

Ōita, , Japan

Site Status

Saitama, , Japan

Site Status

Tokushima, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=1226-CL-A003

Link to results on Astellas Clinical Study Results Web site

Other Identifiers

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275-10-001

Identifier Type: OTHER

Identifier Source: secondary_id

1226-CL-A003

Identifier Type: -

Identifier Source: org_study_id

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