Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01248780
First received: November 24, 2010
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Golimumab
Drug: Placebo
Drug: Methotrexate (MTX)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.


Secondary Outcome Measures:
  • Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of "Good" or "Moderate" at Week 14. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14.

  • American College of Rheumatology 20 Response, Using CRP, at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.

  • HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ.


Enrollment: 264
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab + methotrexate (MTX)
Participants will receive golimumab 50 mg as subcutaneous (SC) (under the skin) injections administered every 4 weeks for up to 48 weeks. In addition, participants will receive a stable dose of MTX.
Drug: Golimumab
50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks
Drug: Methotrexate (MTX)
A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.
Experimental: Placebo + methotrexate (MTX)
Participants will be administered Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48. In addition, participants will receive a stable dose of MTX.
Drug: Placebo
Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.
Drug: Methotrexate (MTX)
A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.

Detailed Description:

Golimumab is a type of tumor necrosis factor (TNF)-inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, a 50% chance to receive golimumab and a 50% chance to receive placebo. If the patient does not have an improvement in their joints at the Week 16 visit compared to when they entered the study, and are in Group 1 (placebo group), the patient will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), the patient will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and is still receiving placebo injections, because there was improvement in their joints at Week 16, the patient will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or is already receiving golimumab injections at week 24, the patient will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (e.g., blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks from randomization (Week 0) until Week 48.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis for at least 6 months

  • Be on a stable dose of methotrexate for 4 weeks
  • Have at least 4 swollen and 4 tender joints

Exclusion Criteria:

  • Prior exposure to biologic anti-TNFalpha agents
  • Inflammatory diseases other than rheumatoid arthritis
  • Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent
  • History of, or ongoing, chronic or recurrent infectious disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248780

Locations
China
Beijing, China
Chengdu, China
Hefei, China
Jinan, China
Nanjing, China
Shanghai, China
Suzhou, China
Wuhan, China
Xi'An, China
Sponsors and Collaborators
Centocor, Inc.
Schering-Plough
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01248780     History of Changes
Other Study ID Numbers: CR015913, C0524T28
Study First Received: November 24, 2010
Results First Received: October 5, 2012
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
Rheumatoid Arthritis
injection
golimumab
simponi

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014