An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

NCT00896168 | Completed Phase 4 Results

• 2 other identifiers: CR015460REMICADEART4005
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid; Infliximab; Methotrexate

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response

  ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).

  Week 26

• Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response

  ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).

  Week 26

• Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response

  ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).

  Week 26

Secondary Outcomes (9)

• Change From Baseline in Swollen Joints Count at Week 26

  Baseline and Week 26

• Change From Baseline in Tender Joints Count at Week 26

  Baseline and Week 26

• Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26

  Baseline and Week 26

• Change From Baseline in Participants' Global Disease Assessment at Week 26

  Baseline and Week 26

• Change From Baseline in Physicians' Global Disease Assessment at Week 26

  Baseline and Week 26

Study Arms (2)

Infliximab + Methotrexate (Moderate RA)

EXPERIMENTAL

Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score \[DAS\] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.

Drug: Infliximab; Drug: Methotrexate

Infliximab + Methotrexate (Severe RA)

EXPERIMENTAL

Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.

Drug: Infliximab; Drug: Methotrexate

Interventions

Infliximab DRUG

Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.

Infliximab + Methotrexate (Moderate RA); Infliximab + Methotrexate (Severe RA)

Methotrexate DRUG

MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.

Infliximab + Methotrexate (Moderate RA); Infliximab + Methotrexate (Severe RA)

Eligibility Criteria

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

You may qualify if:

• Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the American College of Rheumatology Criteria 1987
• Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for at least 4 weeks
• Participants using oral corticosteroids, must have been on a stable dose of prednisone less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before screening or if currently not using corticosteroids, the participant must not have received corticosteroids for at least 4 weeks before screening
• Participants with moderate to severe RA (Disease Activity Score \[DAS28\] greater than 3.2)
• Male participants shall adopt contraceptive measures during the trial and within 6 months after the completion of trial (such as spermicidal barrier), or their female sexual partners shall agree to adopt effective contraceptive measures during the trial or within 6 months after the completion of trial (such as oral contraceptives, contraceptives for injection, intrauterine device \[IUD\], or sterilization by surgery); female participants of childbearing potential with negative urine pregnancy test upon enrollment in addition to adopting the said contraceptive measures

You may not qualify if:

• Participant who has a known allergy to human immunoglobulin proteins or other components of infliximab
• Participant who has a history of receiving infliximab or any other biological preparations
• Participant who is in stage IV RA evaluated by X-ray
• Participants suffering from tuberculosis
• Female participant or male participant's wife who plans to become pregnant during this study and within 6 months after completion of this study

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: Xian-Janssen Pharmaceutical Ltd

(8610) 5821 8359

Study Officials

• Xian-Janssen Pharmaceutical Ltd. Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 13, 2013
• Results First Posted: September 13, 2013

Record last verified: 2013-09