Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis

NCT00051662 | Completed Phase 1

• 1 other identifier: HUPA600
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Psoriatic Arthritis

Interventions

efalizumab DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• XOMA (US) LLC: lead

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2003
• First Posted: January 16, 2003
• Study Completion: February 1, 2004
• Last Updated: June 24, 2005

Record last verified: 2004-09