An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis

NCT00267956 | Completed Phase 2 Results DMC

• 3 other identifiers: CR006322C0743T102005-003525-92
• Study Type: interventional
• Target: 146
• Locations: 5 countries
• Sites: 25

Brief Summary

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

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; CNTO 1275; Ustekinumab; Interleukin-23, IL-12, IL-23; Monoclonal antibodies

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12

  ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).

  Week 0 to Week 12

Secondary Outcomes (5)

• Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12

  Week 12

• Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12

  Week 12

• Change in Health Assessment Questionnaire (HAQ) at Week 12

  Week 0 to Week 12

• Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12

  Week 12

• Change in Dermatology Life Quality Index (DLQI) at Week 12

  Week 0 to Week 12

Study Arms (2)

CNTO1275 (ustekinumab)

EXPERIMENTAL

Group 1: Patients will receive CNTO 1275 63 mg at Weeks 0, 1, 2, and 3. At Weeks 12 and 16, patients will receive placebo to maintain the blind.

Drug: CNTO 1275 63 mg; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Group 2: Patients will receive placebo at Weeks 0, 1, 2, and 3. At Weeks 12 and 16, patients will receive CNTO 1275 63 mg.

Drug: CNTO 1275 63 mg; Drug: Placebo

Interventions

CNTO 1275 63 mg DRUG

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.

CNTO1275 (ustekinumab); Placebo

Placebo DRUG

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

CNTO1275 (ustekinumab); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (25)

Unknown Facility

Macon, Georgia, United States

Location

Unknown Facility

Boise, Idaho, United States

Location

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Normal, Illinois, United States

Location

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Indianapolis, Indiana, United States

Location

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Covington, Louisiana, United States

Location

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Boston, Massachusetts, United States

Location

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Ann Arbor, Michigan, United States

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Las Vegas, Nevada, United States

Location

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New Brunswick, New Jersey, United States

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New York, New York, United States

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Wilmington, North Carolina, United States

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Salt Lake City, Utah, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

Location

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Surrey, British Columbia, Canada

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Aarhus C, Denmark

Location

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Hellerup, Denmark

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København NV, Denmark

Location

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Hus, Finland

Location

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Tampere, Finland

Location

Unknown Facility

Geneva, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30739254 DERIVED

• 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.

  PMID: 19217154 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The count of patients with any nonserious adverse event (NAE) excludes patients who only had NAE that occured in \<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirements of this website.

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Centocor Research & Development, Inc

1-800-457-6399

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 22, 2005
• Study Start: December 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 5, 2013
• Results First Posted: September 5, 2012

Record last verified: 2013-05

Locations

CH (1); CA (7); DK (3); FI (2); US (12)