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An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

NCT ID: NCT00207714

Last Updated: 2012-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-02-28

Brief Summary

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Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Detailed Description

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This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis CNTO 148 Methotrexate Joint pain Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Golimumab (CNTO 148) with Methotrexate (MTX)

Group Type EXPERIMENTAL

Golimumab

Intervention Type DRUG

Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.

MTX

Intervention Type DRUG

Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous

Infliximab with MTX

Group Type EXPERIMENTAL

MTX

Intervention Type DRUG

Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous

Infliximab

Intervention Type DRUG

Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Placebo with MTX

Group Type PLACEBO_COMPARATOR

MTX

Intervention Type DRUG

Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous

Placebo

Intervention Type DRUG

Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous

Interventions

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Golimumab

Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.

Intervention Type DRUG

MTX

Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous

Intervention Type DRUG

Placebo

Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous

Intervention Type DRUG

Infliximab

Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
* Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria

* Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
* Received disease-modifying antirheumatic drugs (\[DMARDs\] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin \[IL\]-1 receptor antagonist \[anakinra\], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor BV

INDUSTRY

Sponsor Role collaborator

Centocor, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Janssen R&D US

Principal Investigators

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Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

References

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Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383.

Reference Type DERIVED
PMID: 18383539 (View on PubMed)

Other Identifiers

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C0524T02

Identifier Type: OTHER

Identifier Source: secondary_id

CR005263

Identifier Type: -

Identifier Source: org_study_id