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Arthritis, PsoriaticPhase 3NCT00367237

Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)

A Phase 3 study testing Infliximab + methotrexate (IFX + MTX) and Methotrexate (MTX) in people with Arthritis, Psoriatic, run by Merck Sharp & Dohme LLC.

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

This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Infliximab + methotrexate (IFX + MTX) and Methotrexate (MTX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
No sites listed yet
Study dates
May 2006to Mar 2008
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must meet ALL of the criteria listed below for entry into the study:
  • Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subject aged 18 years or more, of either sex and any race
  • Diagnosis of Psoriatic Arthritis with peripheral polyarticular involvement. Patients will have at least one of the following:
  • Distal Interphalangeal Joints (DIP) involvement
  • polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
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  • arthritis mutilans
  • asymmetric peripheral arthritis
  • Negative rheumatoid factor
  • The disease should have been diagnosed at least 3 months prior to screening.
  • Active disease at the time of screening and prior to receiving the baseline study medication(s) as defined by:
  • 5 or more swollen joints and
  • 5 or more tender joints
  • and one out of the following three categories:
  • Erythrocyte Sedimentation Rate (ESR) >= 28 mm/h
  • C-reactive protein (CRP) >= 15 mg/l
  • Morning stiffness >= 45 min
  • Subjects must confirm that they are practicing adequate contraception: Female subjects of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation).
  • Female subjects of childbearing potential must have a negative pregnancy test at Screening.
  • Subjects must be eligible for anti-tumor necrosis factor (TNF) treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at baseline.
  • If using Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids other than i.v., i.m. or i.a., the patient must be on a stable dose for four weeks prior screening (maximum dose up to 10mg/day of prednisone or its oral equivalent).
  • The screening laboratory tests must beet the following criteria:
  • Hemoglobin >= 10 g/dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation.
  • white blood cell (WBC) >= 3500 / μl
  • Neutrophils >= 1500 / μl
  • Platelets >= 100 000/ μl
  • Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase <= 1.5 x upper limit of normal
  • Total bilirubin <= 1 x upper limit of normal
  • Serum creatinine <= 1.5 mg/dl
  • Patient must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.

Who cannot join

  • The subject will be excluded from entry into the study if ANY of the criteria listed below are met:
  • Subject is a female who is pregnant, intends to become pregnant during the study (or within 6 months after study completion), or nursing.
  • Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis.
  • Previous treatment with Infliximab.
  • Subjects who have previously received MTX or have not discontinued their other DMARD therapy (i.e., sulfasalazine, hydroxychloroquine, leflunomide).
  • Patients with fibromyalgia syndrome.
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  • Use of cyclosporine or tacrolimus within 4 weeks prior to screening. Use of IM, IV, or IA corticosteroids within 4 weeks prior to screening.
  • Treatment with any investigational drug within 3 months prior to screening.
  • Previous treatment with a monoclonal antibody or a fusion protein.
  • A history of known allergy to murine proteins.
  • History of infected joint prosthesis within the previous 5 years.
  • Chronic infections.
  • History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
  • Subject has any clinically significant deviation from normal in the physical examination, chest X-ray, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
  • Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.
  • History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
  • Subject is part of the staff or a family member of the staff personnel directly involved with this study.
  • History of drug abuse.
  • Subjects who are participating in any other clinical study.

About this study

Official title: A Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis

This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.

Being tested
Infliximab + methotrexate (IFX + MTX), Methotrexate (MTX)
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • Infliximab + methotrexate (IFX + MTX)Drug

    Also called Group 1, Remicade + MTX

    Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6.

  • Methotrexate (MTX)Drug

    Also called Group 2, MTX

    Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.

Study groups in NCT00367237
Study groupRoleWhat they receive
Infliximab + methotrexate (IFX + MTX)ExperimentalRemicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Receives: Drug: Infliximab + methotrexate (IFX + MTX)
Methotrexate (MTX)Active comparatorOral methotrexate (MTX) 15 mg/week
Receives: Drug: Methotrexate (MTX)

What is being measured

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

  1. Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16

    >=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.

    Measured: between baseline and week 16

Secondary outcomes (3)

  1. Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable

    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

    Measured: between baseline and week 16

  2. Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)

    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

    Measured: between baseline and week 16

  3. Adverse Events

    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.

    Measured: between baseline and week 16

Timeline

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

  1. First posted22 Aug 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMar 2008
  4. Study completionMar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00367237
Sponsor's protocol ID
P04422
Other IDs
EUDRACT #: 2005-002189-12
Status last verified
Mar 2017
First submitted
18 Aug 2006
Last updated
11 Apr 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Baranauskaite A, Raffayova H, Kungurov NV, Kubanova A, Venalis A, Helmle L, Srinivasan S, Nasonov E, Vastesaeger N; RESPOND investigators. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study. Ann Rheum Dis. 2012 Apr;71(4):541-8. doi: 10.1136/ard.2011.152223. Epub 2011 Oct 12.

    PubMed 21994233

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab + methotrexate (IFX + MTX) and Methotrexate (MTX) in people with Arthritis, Psoriatic, run by Merck Sharp & Dohme LLC.

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 30 inclusion and 19 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 11 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Jul 2009). 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?

Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16 (time frame: between baseline and week 16). 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 NCT00367237, which also lists 1 linked publication.

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 11 Apr 2017.

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