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

NCT00207714 | Completed Phase 2 Results

• 2 other identifiers: CR005263C0524T02
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; CNTO 148; Methotrexate; Joint pain; Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16

  ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).

  Week 16

Secondary Outcomes (1)

• Summary of ACR-N, Index of Improvement at Week 16

  Week 16

Study Arms (3)

Golimumab (CNTO 148) with Methotrexate (MTX)

EXPERIMENTAL

Drug: Golimumab; Drug: MTX

Infliximab with MTX

EXPERIMENTAL

Drug: MTX; Drug: Infliximab

Placebo with MTX

PLACEBO COMPARATOR

Drug: MTX; Drug: Placebo

Interventions

Golimumab DRUG

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

Golimumab (CNTO 148) with Methotrexate (MTX)

MTX DRUG

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

Golimumab (CNTO 148) with Methotrexate (MTX); Infliximab with MTX; Placebo with MTX

Placebo DRUG

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

Placebo with MTX

Infliximab DRUG

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

Infliximab with MTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead
• Centocor BV: collaborator

Related Publications (1)

• 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.

  PMID: 18383539 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthralgia; Arthritis

Interventions

golimumab; Infliximab

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Results Point of Contact

• Title: Director Clinical Research
• Organization: Centocor Research & Development, Inc.

1-800-457-6399

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2003
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2006
• Last Updated: October 18, 2012
• Results First Posted: August 7, 2012

Record last verified: 2012-10