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Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

NCT ID: NCT00791999

Last Updated: 2012-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-01-31

Brief Summary

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The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : 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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis Certolizumab Pegol Cimzia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CDP870 100mg

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks

Group Type EXPERIMENTAL

CDP870 100mg

Intervention Type DRUG

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)

CDP870 200mg

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks

Group Type EXPERIMENTAL

CDP870 200mg

Intervention Type DRUG

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)

CDP870 400mg

400mg CDP870 given every 2 weeks

Group Type EXPERIMENTAL

CDP870 400mg

Intervention Type DRUG

400mg CDP870 given every 2 weeks until Week22 (SC)

Placebo

Placebo given every 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo of CDP870

Intervention Type DRUG

given every 2 weeks until Week22 (SC)

Interventions

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CDP870 400mg

400mg CDP870 given every 2 weeks until Week22 (SC)

Intervention Type DRUG

CDP870 200mg

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)

Intervention Type DRUG

CDP870 100mg

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)

Intervention Type DRUG

Placebo of CDP870

given every 2 weeks until Week22 (SC)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katsuhisa Saito

Role: STUDY_CHAIR

OPCJ

Locations

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Chubu Region, , Japan

Site Status

Chugoku Region, , Japan

Site Status

Hokkaido Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Kinki Region, , Japan

Site Status

Kyushuh Region, , Japan

Site Status

Shikoku Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Countries

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Japan

References

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Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Shoji T, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol. 2014 Sep;24(5):715-24. doi: 10.3109/14397595.2013.864224. Epub 2013 Dec 9.

Reference Type DERIVED
PMID: 24313916 (View on PubMed)

Other Identifiers

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JapicCTI-080665

Identifier Type: OTHER

Identifier Source: secondary_id

CDP870-275-08-001

Identifier Type: -

Identifier Source: org_study_id