Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC

Criteria

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