The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: infliximab; methotrexate
Intervention description: The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.; Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Intervention MeSH terms: Infliximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 868.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label
      study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the
      treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to
      severe plaque-type psoriasis for at least 6 months prior to screening (subjects with
      concurrent psoriatic arthritis may also be enrolled).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate
             to severe plaque-type psoriasis for at least 6 months prior to study screening
             (subjects with concurrent psoriatic arthritis may also be enrolled).

          -  Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and
             must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater
             and have at least 10% of their total body surface area (BSA) involved at Baseline.

          -  Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or
             other ultraviolet light sources during the study.

          -  Subjects must also meet the tuberculosis (TB) eligibility assessment and screening
             criteria as follows: Have no history of latent or active TB prior to screening; have
             no signs or symptoms suggestive of active TB upon medical history and/or physical
             examination; have had no recent close contact with a person with active TB or, if
             there has been such contact, will be referred to a physician specializing in TB to
             undergo additional evaluation and, if warranted, receive appropriate treatment for
             latent TB prior to or simultaneously with the first administration of study
             medication; within 1 month prior to the first administration of study medication,
             either have negative diagnostic TB test results (defined as 2 negative tuberculin skin
             tests) OR have a newly identified positive diagnostic TB test result (defined as at
             least 1 positive tuberculin skin tests) during screening in which active TB has been
             ruled out and for which appropriate treatment for latent TB has been initiated either
             prior to or simultaneously with the first administration of study medication.

          -  Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months
             prior to Screening with no evidence of malignancy, infection, fibrosis, or current or
             old active TB.

          -  Specific parameters must also be met with regard to screening laboratory test results
             and liver enzymes in order to be eligible to participate in the study.

        Exclusion Criteria:

          -  Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are
             pregnant, nursing, or planning pregnancy;

          -  Subjects previously treated with MTX or infliximab; subjects who are taking specific
             drugs within the specified time frame prior to Baseline as follows: any therapeutic
             agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or
             bacterial vaccinations within 3 months; any systemic medications or treatments that
             could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or
             lithium within 4 weeks; any topical medications or treatments that could affect
             psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for
             psoriasis are shampoos (containing tar or salicylic acid only) and topical
             moisturizers. Subjects should not use these topical agents during the morning prior to
             a study visit. Non-medicated shampoos may be used on the morning of a visit.

          -  Subjects with poor health, including concomitant congestive heart failure (CHF);
             history of chronic or recurrent infectious disease, as specified; human
             immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms
             suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or
             who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who
             have been hospitalized or received IV antibiotics, or who had an opportunistic
             infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis,
             or mycobacteria other than TB), or a transplanted organ within specified time frames;
             or other conditions as specified in the protocol.

          -  Subjects who have used any investigational drugs within 4 weeks of Screening, who are
             participating in other clinical studies, staff or family members of study staff are
             excluded from participation in the study.