Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
Study Details
Study Description
Brief Summary
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)
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
A phase II, randomized, double-blind, placebo-controlled study to:
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Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis (PsA).
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Evaluate the safety, tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion criteria:
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Diagnosed with PsA as defined by:
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Presence of psoriasis with at least one 2 cm plaque AND
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One of the five functional classifications of PsA
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Functional Class I, II, or III as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
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Moderate to severe disease, defined as follows:
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At least 3 tender and 3 swollen joints (78 joint count for tenderness and 76 joints for swelling; AND
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Either ESR ≥ 28 mm/hr, CRP ≥ 1.5 mg/dL, or morning stiffness for ≥ 30 minutes.
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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.
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18 to 80 years of age.
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Body weight ≤ 125 kg (275 lbs).
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Candidate for systemic immunomodulatory therapy.
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Using an acceptable method of birth control.
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If female, must have a negative serum pregnancy test during screening period, must be surgically sterile, or must be at least five years postmenopausal.
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Informed about the study and signed an informed consent prior to performance of any study-related procedure.
Exclusion criteria:
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Previous treatment with efalizumab.
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Rheumatoid Factor positive without dactylitis or positive X-rays of the hands or feet, or with rheumatoid nodules.
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History of joint replacement surgery within 60 days prior to the start of study drug dosing.
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Joint replacement therapy planned within nine months subsequent to the start of study drug dosing.
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Intra-articular cortisone injections within 28 days prior to the start of study drug dosing.
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Pregnancy or lactation.
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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.
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Active bacterial, viral, fungal, mycobacterium tuberculosis or atypical mycobacterium infection.
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Positive PPD test unless subject with positive PPD test completed a course of treatment for tuberculosis
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History of any opportunistic infection.
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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.
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Received any vaccine within 28 days prior to the start of study drug dosing.
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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).
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COPD, asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily.
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Failed to respond or maintain response to Enbrel.
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Received any DMARD other than methotrexate or sulfasalazine during the 28 days prior to the start of study drug dosing.
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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.
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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.
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Any condition which, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to efalizumab.
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Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function (AST or ALT ≥ 2.5
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ULN).
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Serum creatinine level ≥ 1.5 mg/dL
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Platelet count ≤ 125,000 cells/mm3
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WBC count ≤ 3,500 cells/mm3
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Total lymphocyte count ≤ 1000 cells/mm3
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Seropositive for hepatitis B
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Seropositive for hepatitis C antibody
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Seropositive for HIV
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Antinuclear antibodies titer ≥ 1:80
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History of inflammatory bowel disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- XOMA (US) LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUPA600