An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: CNTO 1275 63 mg; Placebo
Intervention description: The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16.; The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis; CNTO 1275; Ustekinumab; Interleukin-23, IL-12, IL-23; Monoclonal antibodies

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275
      (ustekinumab) in patients with psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had active psoriatic arthritis for at least 6 months prior to administration of
             first study injection

          -  Have an active plaque psoriasis (defined as a lesion of at least 2 cm in diameter),
             but not in armpits, on chest between breasts or groin

          -  Women of childbearing potential and all men must be using an effective method of birth
             control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier
             method with spermicide, or surgical sterilization) and must agree to continue to use
             such measures until 12 months after receiving the last injection of study agent

          -  Have an active arthritis despite disease-modifying anti-rheumatic drugs (DMARD) such
             as leflunomide, gold, sulfasalazine, but not including methotrexate) or non-steroidal
             anti-inflammatory agents (NSAID) such as aspirin, ibuprofen, naproxen) therapy. DMARD
             therapy is defined as taking a DMARD for at least 3 months, or evidence of not
             tolerating DMARD. NSAID therapy is defined as taking an NSAID for at least 4 weeks

          -  If the patients are using methotrexate (MTX), they should have started treatment at
             least 3 months prior to the first administration of study agent and should have no
             serious toxic side effects attributable to MTX

          -  Have no signs or symptoms suggestive of active tuberculosis upon medical history,
             physical examination and chest X-ray

        Exclusion Criteria:

          -  Have received DMARDs, other than methotrexate, within 4 weeks prior to the
             randomization visit

          -  Have used any biologic within the previous 3 months or 5 times the half-life of the
             biologic, whichever is longer

          -  Have received any oral, intravenous or intramuscular medications/treatments that could
             affect psoriasis (including, but not limited to, oral or injectable corticosteroids,
             retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine,
             hydroxyurea, fumaric acid derivatives, or phototherapy) within 4 weeks of the
             randomization visit and/or have used topical medications/treatments that could affect
             psoriasis (eg, corticosteroids, anthralin, calcipotriene, topical vitamin D
             derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens) within 2 weeks of
             the randomization visit

          -  Have a history of chronic or recurrent infectious disease, including but not limited
             to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent
             urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis),
             or open, draining, or infected skin wounds or ulcers

          -  Have a history of latent or active granulomatous infection, including tuberculosis
             (TB), histoplasmosis, or coccidioidomycosis, prior to screening

          -  Have current signs or symptoms of severe, progressive, or uncontrolled kidney, liver,
             blood, intestinal, hormonal, lung, heart, nervous, brain, or psychiatric disease

          -  Have any known cancer or have a history of cancer within the previous 5 years (with
             the following exception: have had basal cell carcinoma or squamous cell carcinoma in
             situ of the skin that has been treated, with no evidence of recurrence)