Back to resultsAn Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Infliximab
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Rheumatoid, Infliximab, Methotrexate
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Infliximab + Methotrexate (Moderate RA)
Infliximab + Methotrexate (Severe RA)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
Change From Baseline in Swollen Joints Count at Week 26
Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).
Change From Baseline in Tender Joints Count at Week 26
Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).
Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26
Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).
Change From Baseline in Participants' Global Disease Assessment at Week 26
Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale.
Change From Baseline in Physicians' Global Disease Assessment at Week 26
Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale.
Change From Baseline in Duration of Morning Stiffness at Week 26
Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26
The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.
Change From Baseline in C-Reactive Protein (CRP) at Week 26
CRP is a protein found in the blood, the levels of which rise in response to inflammation.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26
ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.
Full Information
NCT ID
NCT00896168
First Posted
May 7, 2009
Last Updated
September 11, 2013
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00896168
Brief Title
An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Official Title
A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 [DAS 28]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along 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. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Arthritis, Rheumatoid, Infliximab, Methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infliximab + Methotrexate (Moderate RA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Infliximab + Methotrexate (Severe RA)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response
Description
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).
Time Frame
Week 26
Title
Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response
Description
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).
Time Frame
Week 26
Title
Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response
Description
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).
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Swollen Joints Count at Week 26
Description
Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).
Time Frame
Baseline and Week 26
Title
Change From Baseline in Tender Joints Count at Week 26
Description
Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).
Time Frame
Baseline and Week 26
Title
Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26
Description
Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).
Time Frame
Baseline and Week 26
Title
Change From Baseline in Participants' Global Disease Assessment at Week 26
Description
Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale.
Time Frame
Baseline and Week 26
Title
Change From Baseline in Physicians' Global Disease Assessment at Week 26
Description
Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale.
Time Frame
Baseline and Week 26
Title
Change From Baseline in Duration of Morning Stiffness at Week 26
Description
Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Week 26
Title
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26
Description
The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.
Time Frame
Baseline and Week 26
Title
Change From Baseline in C-Reactive Protein (CRP) at Week 26
Description
CRP is a protein found in the blood, the levels of which rise in response to inflammation.
Time Frame
Baseline and Week 26
Title
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26
Description
ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.
Time Frame
Baseline and Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Janssen Pharmaceutical Ltd. Clinical Trial
Organizational Affiliation
Xian-Janssen Pharmaceutical Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
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