A Study of the Safety and Efficacy of CNTO 1275 in Patients With Active Psoriatic Arthritis - Full Text View

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00267956

Purpose

The purpose of this study is to evaluate the effiacy (improvement of signs and symptoms) and safety of an antibody to IL-12 (interleukin: protein used to stimulate immune systems) and IL-23 [CNTO 1275] in psoriatic arthritis.

Condition	Intervention	Phase
Subcutaneous Injection Psoriatic Arthritis	Drug: CNTO 1275, monoclonal antibody to IL-12p40 and IL-23 p40 subunits	Phase II

Drug Information available for: Immunoglobulins Globulin, Immune Interleukin-12 Ustekinumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

The primary endpoint of this study is to see whether a greater number of subjects who receive 4 doses of CNTO 1275 90 mg have 20% (or more) improvement from baseline in their American College of Rheumatology arthritis scores at Week 12

Secondary Outcome Measures:

Secondary outcomes are to see whether more subjects treated with CNTO 1275 have 50% or 70% improvement in arthritis scores, improvements in quality of life assessments and greater numbers of subjects with 75% improvement in psoriasis scores at Week 12.

Estimated Enrollment:	140
Study Start Date:	December 2005
Study Completion Date:	September 2007

Detailed Description:

While anti-TNF(Tumor necrosis factor) molecules and other disease modifying agents show effectiveness in patients with psoriatic arthritis, there are reasons to study new agents targeting different areas of inflammation. Also, there is potential to improve the response further over available therapy and to treat patients who do not repond to the available therapies. There is considerable evidence of the role of IL-12, in the development and worsening of experimental animal arthritis models. Studies in humans have suggested a role for IL-12 as causing worsening arthritis. Hence the scientific question to be asked is whether blocking IL-12 and IL-23 with antibodies will lead to improvement in both arthritis and psoriasis skin lesions in patients with psoriatic arthritis. Improvement of psoriasis with CNTO 1275 has been demonstrated in a Phase II study.This study is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group, muticenter study to evaluate the effectiveness and safety of CNTO 1275 compared to placebo in the treatment of patients with active psoriatic arthritis. The primary effectiveness endpoint will be measured by the reduction in signs and symptoms of arthritis, as defined by 20% improvement from baseline American College of Rheumatology (ACR) measurements of arthritis at Week 12. The study will additionally look at higher levels of joint improvement (i.e. 50% or 70% improvement from baseline, improvements in skin lesions, improvement in activity and quality of life), as well as the impact of CNTO1275 on psoriatic skin lesions and quality of life. Patients who qualify by fulfilling all inclusion and exclusion criteria listed below will come to their site for a screening evaluation which includes testing for tuberculosis (skin test and chest x-ray). Patients will be asked to give consent to participate in the study prior to any study specific procedures and will then have full medical histories taken and physical examinations, including height, weight and vital signs. Appropriate blood tests and pregnancy tests if applicable will be performed. If the subject fulfills all of these examinations and is thought to be a candidate for this study, they will be entered in the study at the judgement of the investigator at the site.

Seventy patients will receive CNTO 1275 90 mg subcutaneously (under the skin) at Weeks 0,1,2 and 3. They will then receive placebo subcutaneous injections at Weeks 12 and 16. Seventy patients will receive placebo injections at Weeks 0, 1,2 and 3 and CNTO 1275 90 mg subcutaneously at Weeks 12 and 16.

Eligibility

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

Criteria

Inclusion Criteria:

1 Active psoriatic arthritis for at least 6 months prior to administration of first study injection
2 Active plaque psoriasis (defined as a lesion of at least 2 cm in diameter), but not in armpits, on chest between breasts or groin
3 Women of childbearing potential and all men must be using adequate 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
4 Have active arthritis despite DMARDs (disease modifying agents such as leflunomide, gold, sulfasalazine but not including methotrexate) or NSAID (non-steroidal anti-inflammatory agents 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
5 If using methotrexate, patients 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 methotrexate. Methotrexate route of administration and doses (not to exceed 25 mg/week) should be stable for at least 4 weeks prior to the randomization visit
6 Have no signs or symptoms suggestive of active tuberculosis upon medical history, physical examination and chest X-ray

Exclusion Criteria:

1. Have received DMARDs other than MTX within 4 weeks prior to the randomization visit
2. Have used any biologic within the previous 3 months or 5 times the half-life of the biologic, whichever is longer. (ask your doctor)
3. 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 - 4. 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
5. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
6. Have current signs or symptoms of severe, progressive, or uncontrolled kidney, liver, blood, intestinal, hormonal, lung, heart, nervous, brain, or psychiatric disease
7. Have any known cancer or have a history of cancer within the previous 5 years (with the following exceptions: have had basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence
8. Have not been treated with phototherapy and have had no more than 1 squamous cell carcinoma of the skin that has been treated with no evidence of recurrence)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267956

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Study ID Numbers:	CR006322
Study First Received:	December 20, 2005
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00267956
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Psoriatic Arthritis, biologic, CNTO 1275, Interleukin-12, Interleukin-23, IL-12, IL-23

Study placed in the following topic categories:

Spinal Diseases
Interleukin-12
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
Bone Diseases
Antibodies, Monoclonal

Antibodies
Musculoskeletal Diseases
Psoriasis
Arthritis
Spondylarthritis
Skin Diseases, Papulosquamous
Immunoglobulins
Spondylarthropathies

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009