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Arthritis, RheumatoidPhase 4NCT00896168

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

A Phase 4 study testing Infliximab and Methotrexate in people with Arthritis, Rheumatoid, run by Xian-Janssen Pharmaceutical Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Infliximab and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
No sites listed yet
Study dates
Jun 2007to Apr 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis

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.

Read the 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.

Keywords
Arthritis, Rheumatoid, Infliximab, Methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

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

  • MethotrexateDrug

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

Study groups in NCT00896168
Study groupRoleWhat they receive
Infliximab + Methotrexate (Moderate RA)ExperimentalParticipants 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.
Receives: Drug: Infliximab; Drug: Methotrexate
Infliximab + Methotrexate (Severe RA)ExperimentalParticipants 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.
Receives: Drug: Infliximab; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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).

    Measured: 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).

    Measured: Week 26

Secondary outcomes (9)

  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).

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2009 (estimated)
  2. Study startJun 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00896168
Sponsor's protocol ID
CR015460
Other IDs
REMICADEART4005
Status last verified
Sep 2013
First submitted
7 May 2009
Last updated
13 Sep 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Infliximab and Methotrexate in people with Arthritis, Rheumatoid, run by Xian-Janssen Pharmaceutical Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response (time frame: Week 26). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00896168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.

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