Long-term Treatment Study of CDP870 Without Coadministration of MTX in Japanese Rheumatoid Arthritis (RA) Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

UCB Japan Co. Ltd.

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT00850343

First received: February 23, 2009

Last updated: November 19, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 23, 2009
Last Updated Date	November 19, 2012
Start Date ^ICMJE	March 2009
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2009)	Adverse events [ Time Frame: At any time ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00850343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 24, 2009)	ACR20/50/70 responder rate [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ] DAS28(ESR) [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ] Modified Total Sharp Score [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-term Treatment Study of CDP870 Without Coadministration of MTX in Japanese Rheumatoid Arthritis (RA) Patients
Official Title ^ICMJE	A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
Brief Summary	The objectives of this study is to evaluate the safety and efficacy of CDP870 when administered without coadminiatration of MTX over the long term in Japanese RA patients who are transferred from the study (Study 275-08-003), as well as to evaluate the effects of dosing regimens on safety and efficacy of CDP870 in the ACR20 responders who completed Study 275-08-003.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: CDP870 200mg 200 mg CDP870 given every 2 weeks, SC Drug: CDP870 400mg 400 mg CDP870 given every 4 weeks, SC
Study Arm (s)	Experimental: 1 CDP870 200mg: Experimental: 200mg CDP870 given every 2 weeks Intervention: Drug: CDP870 200mg Experimental: 2 CDP870 400mg: Experimental: 400mg CDP870 given every 4 weeks Intervention: Drug: CDP870 400mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	130
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjecs who participated in Study 275-08-003 and meet all of the criteria described below. Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.. Exclusion Criteria: Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003. Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines). Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003. Patients who required treatment for the same infection at two or more different times during Study 275-08-003 Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months. Patients whom the investigator has decided to be inappropriate for participation in the study
Gender	Both
Ages	20 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT00850343
Other Study ID Numbers ^ICMJE	CDP870-275-08-004, JapicCTI-090701
Has Data Monitoring Committee	No
Responsible Party	Otsuka Pharmaceutical Co., Ltd.
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	UCB Japan Co. Ltd.
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Co., Ltd.
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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