A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis

NCT ID: NCT00281294

Last Updated: 2008-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2006-12-31

Brief Summary

To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Week 14 (Stage A of study).

Detailed Description

To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Week 14 (Stage A of study).

Stage B of this trial is Double blind.

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fontolizumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, at least 18 years of age
• A diagnosis of RA according to ACR criteria (Appendix D, American College of Rheumatology Clinical Classification Criteria for Rheumatoid Arthritis)
• RA functional class I, II, or III (Appendix E, ACR Revised Criteria for Classification of Functional Status in Rheumatoid Arthritis ) for at least 6 months
• Active RA with ≥ 6 tender joints and ≥ 6 swollen joints within one week of dosing or on Day 0, before dosing
• Serum CRP ≥ 1.0 mg/dL (10 mg/L) or ≥ 45 minutes of morning stiffness
• On stable doses for at least 30 days before receiving study drug of at least one, but not more than two, of the following disease-modifying antirheumatic drugs (DMARDs): hydroxychloroquine, leflunomide, methotrexate (leflunomide-methotrexate combination is unacceptable), or sulfasalazine. If being treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose prednisone (≤ 10 mg/day), must be on stable regimen for at least 14 days before receiving study drug
• Women of childbearing potential with a negative serum pregnancy test at screening
• Subjects with reproductive potential agree to use a double-barrier method of contraception during the study and for 3 months after receiving last dose of study drug
• Must provide a signed and dated informed consent and an authorization to use protected health information, have the ability to understand the study requirements, and comply with study procedures, including required study visits

Exclusion Criteria

• Significant involvement of secondary RA (eg, Felty's syndrome, pulmonary fibrosis, Sjogren's syndrome, vasculitis (keratoconjunctivitis sicca is not exclusionary)
• Received a live vaccine within 30 days of receiving fontolizumab
• Received an investigational agent within 30 days or five half-lives of the agent, whichever is longer, of receiving fontolizumab
• Received a corticosteroid injection into any joint, or has been treated with > 10 mg/day of a corticosteroid within 30 days of receiving fontolizumab
• Received etanercept or anakinra within 30 days of receiving fontolizumab
• Received gold salts, infliximab, or adalimumab within 60 days of receiving fontolizumab
• Received IV gamma-globulin or Prosorba column therapy within 90 days of receiving fontolizumab
• Received rituximab or cyclophosphamide within 6 months of receiving fontolizumab
• Failed B cell recovery after exposure to rituximab
• History of hypersensitivity to glycine, histidine, or Polysorbate 80
• Pregnant women or nursing mothers
• Malignancy within 5 years (excluding basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ)
• Known chronic viral infections with HIV, hepatitis B, or hepatitis C
• Clinical, PPD, or clear radiographic evidence of prior TB
• Infection requiring hospitalization or parenteral medication, such as an antibiotic, antiviral, antifungal, or antiparasitic agent, within 90 days of receiving fontolizumab
• History of inflammatory joint disease (eg, gout, Lyme disease, psoriatic arthritis, reactive arthritis, seronegative spondyloarthropathy) or chronic inflammatory diseases (eg, inflammatory bowel disease, inflammatory myopathy, multiple sclerosis, overlap syndrome, scleroderma, systemic lupus erythematosus) other than RA
• Clinically significant unstable or poorly controlled acute or chronic diseases, such as myocardial infarction within 6 months, unstable angina, poorly controlled diabetes or hypertension
• ALT > 1.5 × the upper limit of normal; AST > 1.5 × the upper limit of normal; creatinine 1.5 × the upper limit of normal; absolute neutrophil count (ANC) < 1000/mm3; platelet count < 50,000/mm3
• History of any other medical disease, laboratory abnormalities, or psychological conditions that would make the subject (based upon the principal investigator's judgment) unsuitable for study enrollment
• Current abuse of alcohol or drugs (based upon investigator's assessment)
• Major surgery within 3 months prior to or planned elective surgery during or within 3 months after last dose of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PDL BioPharma, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mark C. Genovese, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University Medical Center-Div. of Rheumatology

Jerry Molitor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Benaroya Research Institute at Virginia Mason

Michael H. Schiff, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Arthritis Clinic

Alan Kivitz, MD

Role: PRINCIPAL_INVESTIGATOR

Altoona Center for Clinical Research

Craig Wiesenhutter, MD

Role: PRINCIPAL_INVESTIGATOR

Coeur d Alene Arthritis Clinic

Justus J. Fiechtner, MD

Role: PRINCIPAL_INVESTIGATOR

Justus Fiechtner MD PC

Daniel Wallace, MD

Role: PRINCIPAL_INVESTIGATOR

Wallace Rheumatic Study Center

Joel Kremer, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Rheumatology

Robert S. Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Associates Clinical Research

Locations

Wallace Rheumatic Study Center

Los Angeles, California, United States

Stanford University Medical Center-Div. of Rheumatology

Palo Alto, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

Coeur d Alene Arthritis Clinic

Coeur d'Alene, Idaho, United States

Rheumatology Associates Clinical Research

Chicago, Illinois, United States

Justus J. Fiechtner MD PC

Lansing, Michigan, United States

The Center for Rheumatology

Albany, New York, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

Countries

United States

References

Wilson JA, Prow NA, Schroder WA, Ellis JJ, Cumming HE, Gearing LJ, Poo YS, Taylor A, Hertzog PJ, Di Giallonardo F, Hueston L, Le Grand R, Tang B, Le TT, Gardner J, Mahalingam S, Roques P, Bird PI, Suhrbier A. RNA-Seq analysis of chikungunya virus infection and identification of granzyme A as a major promoter of arthritic inflammation. PLoS Pathog. 2017 Feb 16;13(2):e1006155. doi: 10.1371/journal.ppat.1006155. eCollection 2017 Feb.

Reference Type: DERIVED

PMID: 28207896 (View on PubMed)

Other Identifiers

ZAF-711

Identifier Type: -

Identifier Source: org_study_id