Efficacy Confirmation Trial of CDP870 as Add-on Medication to MTX in Japanese RA - Full Text View

Sponsors and Collaborators:	Otsuka Pharmaceutical Co., Ltd. UCB Japan CO., LTD.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00791999

Purpose

The objective of this trial is to investigate the efficacy (ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: CDP870 400mg Drug: CDP870 200mg Drug: CDP870 100mg Drug: Placebo of CDP870	Phase II Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as Add-on Medication to Methotrexate (MTX) in Japanese Active Rheumatoid Arthritis (RA) Patients Who Have an Incomplete Response to MTX.

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

ACR20 responder rate [ Time Frame: Week12, 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ACR20/50/70 responder rate [ Time Frame: Week1, 2, 4, 6, 8, 12, 14, 16, 20, 24 ] [ Designated as safety issue: Yes ]
DAS28 (ESR) [ Time Frame: Week1, 2, 4, 6, 8, 12, 14, 16, 20, 24 ] [ Designated as safety issue: Yes ]
Modified Total Sharp Score [ Time Frame: Week24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo given every 2 weeks	Drug: Placebo of CDP870 given every 2 weeks until Week22 (SC)
CDP870 400mg: Experimental 400mg CDP870 given every 2 weeks	Drug: CDP870 400mg 400mg CDP870 given every 2 weeks until Week22 (SC)
CDP870 200mg: Experimental 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks	Drug: CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)
CDP870 100mg: Experimental 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks	Drug: CDP870 100mg 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 (SC)

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.
Subjects must have active RA disease as defined by:
- At least 9 tender joints and 9 swollen joints
- ESR of 30 mm/hour or CRP of 1.5 mg/dL
Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.

Exclusion Criteria:

Patients who have a diagnosis of any other inflammatory arthritis
Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
Patients who currently have, or who have a history of, tuberculosis
Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
Patients who currently have, or who have a history of, malignancy
Female patients who are breastfeeding or pregnant, who are of childbearing potential
Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791999

Contacts

Contact: Drug Information Center

opc_ctr@otsuka.jp

Locations

Japan
	Recruiting
Kanto Region, Japan
	Recruiting
Hokkaido Region, Japan
	Recruiting
Tohoku Region, Japan
	Recruiting
Chubu Region, Japan
	Recruiting
Kyushuh Region, Japan
	Recruiting
Chugoku Region, Japan
	Recruiting
Shikoku Region, Japan
	Recruiting
Kinki Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

UCB Japan CO., LTD.

Investigators

Study Chair:

Katsuhisa Saito

OPCJ

More Information

Responsible Party:	Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd. ( Katsuhisa Saito, Senior Operating Officer )
Study ID Numbers:	CDP870-275-08-001, JapicCTI-080665
Study First Received:	November 14, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00791999
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

Rheumatoid Arthritis
Certolizumab Pegol
Cimzia

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009