Clinical trial NCT00267956: An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
CNTO 1275
Ustekinumab
Interleukin-23, IL-12, IL-23
Monoclonal antibodies
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: This study is a randomized (the study drug is assigned by chance), double-blind (neither physician nor the patient knows the treatment that the patient receives), parallel-group (each group of patients will be treated at the same time), multicenter study to evaluate the effectiveness and safety of CNTO 1275 compared to placebo in the treatment of patients with active psoriatic arthritis. Patients will be randomized in 1:1 ratio to 1 of 2 treatment groups (CNTO 1275 63 mg and placebo). Patients will be randomly assigned to receive study medication up to Week 12 and will be followed through Week 36 to monitor safety and efficacy. Patients randomly assigned to placebo will crossover to receive CNTO 1275 63 mg at Weeks 12 and 16. Patients randomly assigned to CNTO 1275 will receive placebo at Weeks 12 and 16 to maintain the blind. The duration of participation for an individual patient in the study will be up to 36 weeks.

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)

Primary outcomes:
measure: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
timeFrame: Week 0 to Week 12
Secondary outcomes:
measure: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12
timeFrame: Week 12
measure: Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12
timeFrame: Week 12
measure: Change in Health Assessment Questionnaire (HAQ) at Week 12
timeFrame: Week 0 to Week 12
measure: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12
timeFrame: Week 12
measure: Change in Dermatology Life Quality Index (DLQI) at Week 12
timeFrame: Week 0 to Week 12
Other outcomes:
Locations:
city: Macon
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Normal
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Covington
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: New Brunswick
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Wilmington
country: United States
state: North Carolina
city: Salt Lake City
country: United States
state: Utah
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Barrie
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Aarhus C
country: Denmark
city: Hellerup N/A
country: Denmark
city: København Nv
country: Denmark
city: Hus
country: Finland
city: Tampere
country: Finland
city: Genève
country: Switzerland
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
citation: Gottlieb A, Menter A, Mendelsohn A, Shen YK, Li S, Guzzo C, Fretzin S, Kunynetz R, Kavanaugh A. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 2009 Feb 21;373(9664):633-40. doi: 10.1016/S0140-6736(09)60140-9. Epub 2009 Feb 11.