Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00051662
• Date of registration: 14/01/2003
• Primary sponsor: XOMA (US) LLC
• Public title: Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
• Scientific title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis
• Date of first enrolment: January 2001
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00051662
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Drug: efalizumab

Secondary ID(s)

HUPA600

Source(s) of Monetary Support

Please refer to primary and secondary sponsors