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Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422AM1)(COMPLETED)
This study has been completed.
Sponsors and Collaborators: Schering-Plough
Integrated Therapeutics Group
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00367237
  Purpose

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


Condition Intervention Phase
Arthritis, Psoriatic
Drug: Infliximab + methotrexate
Drug: Methotrexate
Phase III

Drug Information available for: Methotrexate Infliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Proportion of subjects achieving ACR20 (> 20% improvement in American College of Rheumatology criteria from baseline) at week 16 [ Time Frame: between baseline and week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving ACR50, ACR70, and PASI75 if applicable [ Time Frame: between baseline and week 16 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: between baseline and week 16 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: between baseline and week 16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 243
Study Start Date: May 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1, Remicade + MTX: Experimental
Remicade 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week
Drug: Infliximab + methotrexate
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.
Group 2, MTX: Active Comparator
Oral methotrexate 15 mg/week
Drug: Methotrexate
Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    • DIP involvement
    • polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
    • 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:

      • ESR >= 28 mm/h
      • 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 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-TNF treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at baseline.
  • If using 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.
    • 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.

Exclusion Criteria:

  • 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.
  • 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 TB guidelines.
  • Subject has any clinically significant deviation from normal in the physical examination, chest X-ray, or 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367237

Sponsors and Collaborators
Schering-Plough
Integrated Therapeutics Group
Investigators
Study Director: Lode Dewulf, MD SP GMA Medical Director, Infectious Diseases
  More Information

Responsible Party: Schering-Plough ( Maarten Kraan, PhD - Senior Global Medical Director, Global Medical Affairs )
Study ID Numbers: P04422, EUDRACT #: 2005-002189-12
Study First Received: August 18, 2006
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00367237  
Health Authority: Russia: Pharmacological Committee, Ministry of Health;   Estonia: The State Agency of Medicine;   Lithuania: State Medicine Control Agency - Ministry of Health;   Egypt: Ministry of Health and Population;   Israel: Israeli Health Ministry Pharmaceutical Administration;   Poland: Ministry of Health;   Slovakia: State Institute for Drug Control;   Hungary: National Institute of Pharmacy;   Romania: State Institute for Drug Control;   Bulgaria: Ministry of Health;   Croatia: Ministry of Health and Social Care;   Slovenia: Agency for Medicinal Products - Ministry of Health;   Turkey: Ministry of Health;   South Africa: National Health Research Ethics Council;   Qatar: Hamad Medical Corporation, Rheumatology Divison-Doha

Study placed in the following topic categories:
Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Infliximab
Joint Diseases
Spondylarthropathy
Bone Diseases
Folic Acid
Musculoskeletal Diseases
Psoriasis
Arthritis
Methotrexate
Spondylarthritis
Skin Diseases, Papulosquamous
Spondylarthropathies

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009