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| Sponsor: | Centocor, Inc. |
|---|---|
| Information provided by: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT01077362 |
Purpose
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Psoriatic |
Drug: placebo Drug: ustekinumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha �Agent(s) |
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | November 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
placebo Subcutaneously (SC) at Wks 0 4 16 20 24 28 40,ustekinumab 45 mg subcutaneously (SC) at Wks 0 4 and every 12 wks to Wk 40,ustekinumab If Early Escape 90 mg subcutaneously (SC) at Wk 16 & every 12 wks to Wk 40
|
Drug: placebo
Subcutaneously (SC) at Wks 0, 4, 16, 20, 24, 28, 40
Drug: ustekinumab
If Early Escape, 90 mg subcutaneously (SC) at Wk 16 & every 12 wks to Wk 40
Drug: ustekinumab
45 mg subcutaneously (SC) at Wks 0, 4 and every 12 wks to Wk 40
|
|
Experimental: 002
placebo Subcutaneously (SC) at Wks 0 4 16 20 24 28 40,ustekinumab 90 mg subcutaneously (SC) at Wks 0 4 and every 12 wks to Wk 40
|
Drug: ustekinumab
90 mg subcutaneously (SC) at Wks 0, 4 and every 12 wks to Wk 40
Drug: placebo
Subcutaneously (SC) at Wks 0, 4, 16, 20, 24, 28, 40
|
|
Experimental: 003
placebo Subcutaneously (SC) at Wks 0 4 16 20 24 28 40,ustekinumab 45 mg subcutaneously (SC) at Wk 24 28 & 40,ustekinumab If Early Escape 45 mg subcutaneously (SC) at Wk 16 20 28 & 40
|
Drug: placebo
Subcutaneously (SC) at Wks 0, 4, 16, 20, 24, 28, 40
Drug: ustekinumab
If Early Escape, 45 mg subcutaneously (SC) at Wk 16, 20, 28 & 40
Drug: ustekinumab
45 mg subcutaneously (SC) at Wk 24, 28 & 40
|
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, multicenter study to evaluate the effectiveness and safety of ustekinumab compared to placebo in the treatment of patients with active psoriatic arthritis who have or are currently receiving treatment with a disease-modifying antirheumatic drug (DMARD) and/or a nonsteroidal anti-inflammatory drug (NSAID), including those who have previously received anti-tumor necrosis factor (anti-TNF) agents [(examples are infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira)]. The primary effectiveness endpoint will be measured by the reduction in signs and symptoms of arthritis, as defined by 20% improvement from baseline in American College of Rheumatology (ACR) measurements of arthritis at Week 24. The study will additionally look at higher levels of joint improvement (ie, 50% or 70% improvement from baseline) and improvement in activity and quality of life, as well as the impact of ustekinumab on psoriatic skin lesions. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure) and the occurrence and severity of adverse events (side effects). Patients will be assigned to one of three treatment groups. Patients will receive either 45 mg ustekinumab, 90 mg ustekinumab, or placebo at Weeks 0, 4 and every 12 weeks until Week 40. Patients who do not have >=5% improvement in their disease (tender and swollen joints) at Week 16 may be eligible to receive an increase or change to their ustekinumab dosage. Ustekinumab 45 mg, 90 mg, or placebo subcutaneous injections at Weeks 0 and 4 followed by every-12-week dosing with the last dose at Week 40. Early escape possibility at Week 16. Patients randomized to placebo will crossover to receive ustekinumab at Weeks 24 and 28 followed by every-12-week dosing with the last dose at Week 40. Expected duration of exposure to study agent including follow up for safety is 60 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Show 90 Study Locations| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
More Information
| Responsible Party: | Senior Director, Clinical Research, Centocor |
| ClinicalTrials.gov Identifier: | NCT01077362 History of Changes |
| Other Study ID Numbers: | CR016483, CNTO1275PSA3002, 2009-012265-60 |
| Study First Received: | February 25, 2010 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Food and Drug Administration Germany: Ethics Commission |
|
Ustekinumab CNTO 1275 Stelara |
Psoriatic Arthritis Psoriasis TNF alpha |
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |