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A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy


This is a Phase III, double blind (neither investigator nor the patient knows the treatment
that the patient receives), placebo-controlled (an inactive substance that is compared with
the study medication to test whether the study medication has a real effect in clinical
study), multicenter, 5-arm (treatment groups) study of golimumab at 2 doses (given with or
without MTX over a period of 30 minutes) for at least 48 weeks in patients with active RA
despite concurrent MTX therapy. The study consists of a treatment period of golimumab IV
infusions for enrolled patients which ranges from 48 weeks to approximately 140 weeks,
assuming an enrollment period of approximately 92 weeks and a long-term extension period, in
which golimumab subcutaneous (SC) injections will be given for 24 weeks. The end of study
will be the time the last patient completes the Week E-40 visit for safety follow-up
assessments. The patients will be randomly assigned to 1 of the 5 treatment groups in a
1:1:1:1:1 ratio (approximately 125 patients per group). Safety will be monitored throughout
the study. The entire study duration for each patient will range from 88 weeks up to 192
weeks, assuming an enrollment period of approximately 92 weeks.


Inclusion Criteria:



- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987
criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender
joints for at least 3 months prior to screening - Have been treated with and tolerated
methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to
screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and
less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non
steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA,
must be on a stable dose for at least 2 weeks prior to the first administration of study
agent

Exclusion Criteria:

- Patients having known hypersensitivity (severe allergy) to human immunoglobulin proteins
or other components of golimumab - Having known clinically serious adverse reaction to a
biologic anti-TNF agent - Have had history of latent or active granulomatous infection,
including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14

Outcome Description:

An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).

Outcome Time Frame:

Week 0 to Week 14

Safety Issue:

No

Principal Investigator

Centocor, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Centocor, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CR012781

NCT ID:

NCT00361335

Start Date:

August 2006

Completion Date:

September 2009

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid arthritis
  • Golimumab
  • Methotrexate
  • Tumor Necrosis Factor-alpha
  • Immunology
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location
Albany, Georgia  31701
Phoenix, Arizona  85012
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Charlotte, North Carolina  
Tulsa, Oklahoma