- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00051662
Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
June 23, 2005 updated by: XOMA (US) LLC
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)
Study Overview
Detailed Description
A phase II, randomized, double-blind, placebo-controlled study to:
- Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis (PsA).
- Evaluate the safety, tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
Study Type
Interventional
Enrollment
45
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
Diagnosed with PsA as defined by:
- Presence of psoriasis with at least one 2 cm plaque AND
- One of the five functional classifications of PsA
- Functional Class I, II, or III as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Moderate to severe disease, defined as follows:
- At least 3 tender and 3 swollen joints (78 joint count for tenderness and 76 joints for swelling; AND
- Either ESR ≥ 28 mm/hr, CRP ≥ 1.5 mg/dL, or morning stiffness for ≥ 30 minutes.
- Currently taking at least one of the following systemic therapies for PsA: pre-existing stable doses of NSAIDs, corticosteroids (≤ 10 mg/day), and either sulfasalazine (≤ 3 gm/day) or methotrexate (≥ 7.5 and ≤ 30 mg/week) but not both.
- 18 to 80 years of age.
- Body weight ≤ 125 kg (275 lbs).
- Candidate for systemic immunomodulatory therapy.
- Using an acceptable method of birth control.
- If female, must have a negative serum pregnancy test during screening period, must be surgically sterile, or must be at least five years postmenopausal.
- Informed about the study and signed an informed consent prior to performance of any study-related procedure.
Exclusion criteria:
- Previous treatment with efalizumab.
- Rheumatoid Factor positive without dactylitis or positive X-rays of the hands or feet, or with rheumatoid nodules.
- History of joint replacement surgery within 60 days prior to the start of study drug dosing.
- Joint replacement therapy planned within nine months subsequent to the start of study drug dosing.
- Intra-articular cortisone injections within 28 days prior to the start of study drug dosing.
- Pregnancy or lactation.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 < 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
- Active bacterial, viral, fungal, mycobacterium tuberculosis or atypical mycobacterium infection.
- Positive PPD test unless subject with positive PPD test completed a course of treatment for tuberculosis
- History of any opportunistic infection.
- History of a malignancy within the past five years. Subjects with a history of fully resolved, resected, basal or squamous cell carcinoma may be enrolled.
- Received any vaccine within 28 days prior to the start of study drug dosing.
- Chronic disorders apart from PsA affecting the joints, such as systemic lupus erythematosus, rheumatoid arthritis, gout, scleroderma or known reactive arthritis (e.g., Reiter's syndrome).
- COPD, asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily.
- Failed to respond or maintain response to Enbrel.
- Received any DMARD other than methotrexate or sulfasalazine during the 28 days prior to the start of study drug dosing.
- Approved biologic PsA therapy during the 28 days or seven half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time; Enbrel within 42 days prior to the start of study drug dosing.
- Investigational drug and/or treatment during the 28 days or 7 half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time.
- Any condition which, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to efalizumab.
Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function (AST or ALT ≥ 2.5
- ULN).
- Serum creatinine level ≥ 1.5 mg/dL
- Platelet count ≤ 125,000 cells/mm3
- WBC count ≤ 3,500 cells/mm3
- Total lymphocyte count ≤ 1000 cells/mm3
- Seropositive for hepatitis B
- Seropositive for hepatitis C antibody
- Seropositive for HIV
- Antinuclear antibodies titer ≥ 1:80
- History of inflammatory bowel disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
February 1, 2004
Study Registration Dates
First Submitted
January 14, 2003
First Submitted That Met QC Criteria
January 15, 2003
First Posted (Estimate)
January 16, 2003
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
September 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUPA600
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriatic Arthritis
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AmgenRecruitingActive Juvenile Psoriatic ArthritisSpain, Turkey, Belgium, France, Greece, Italy, United Kingdom, Austria, Germany, Netherlands, Poland, Romania, Lithuania, South Africa, Portugal
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Universitätsklinikum Hamburg-EppendorfBristol-Myers Squibb; Eli Lilly and Company; UCB Pharma; Merck Sharp & Dohme LLC; AbbVi... and other collaboratorsRecruiting
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Sun Pharmaceutical Industries LimitedActive, not recruitingActive Psoriatic ArthritisUnited States, Australia, Czechia, Germany, India, Japan, Korea, Republic of, Poland, Spain
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AbbVieActive, not recruitingPsoriatic Arthritis (PsA)United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United...
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Sun Pharmaceutical Industries LimitedCompleted
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Bristol-Myers SquibbCompletedActive Psoriatic ArthritisSpain, United States, Hungary, Germany, Poland, United Kingdom, Russian Federation, Italy, Czechia
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Bristol-Myers SquibbCompletedPsoriatic Arthritis (PsA)Germany
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Pope Research CorporationAmgenWithdrawn
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Sun Pharmaceutical Industries LimitedRecruitingActive Psoriatic ArthritisUnited States, Australia, Czechia, Estonia, Korea, Republic of, Poland, Slovakia, Spain, Taiwan, Germany, Italy, India, Canada
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Humanis Saglık Anonim SirketiCompletedPsoriasis and Psoriatic ArthritisIndia
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