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

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Keywords

• Arthritis, Rheumatoid
• Infliximab
• Methotrexate

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 234 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Xian-Janssen Pharmaceutical Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Infliximab + Methotrexate (Moderate RA)

  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

• Experimental
  Infliximab + Methotrexate (Severe RA)

  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

• DrugInfliximab

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

• DrugMethotrexate

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

Primary outcomes

1. 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).

   Time frame: Week 26

2. 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).

   Time frame: Week 26

3. 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).

   Time frame: Week 26

Secondary outcomes

1. 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).

   Time frame: Baseline and Week 26

2. 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).

   Time frame: Baseline and Week 26

3. 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).

   Time frame: Baseline and Week 26

4. 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.

   Time frame: Baseline and Week 26

5. 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.

   Time frame: Baseline and Week 26

6. 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.

   Time frame: Baseline and Week 26

7. 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.

   Time frame: Baseline and Week 26

8. 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.

   Time frame: Baseline and Week 26

9. 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.

   Time frame: Baseline and Week 26

Baseline characteristics