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

NCT00281294 | Terminated Phase 2

• 1 other identifier: ZAF-711
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

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).

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• -Proportion of subjects achieving an American College of Rheumatology response (ACR50) at Week 14 (Stage A).

Secondary Outcomes (12)

• Proportion of subjects achieving ACR20, ACR50, and ACR70 (Stages A and B)

• Change from baseline in serum CRP values (Stages A and B)

• Percent improvement in individual ACR core outcome measures (Stages A and B)

• Change from baseline in DAS28-CRP and ACR-N (Stages A and B)

• ACR-N at each dosing day and at 1 and 3 months after the last dose of study drug (Stages A and B)

Interventions

Fontolizumab DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PDL BioPharma, Inc.: lead

Study Sites (9)

Wallace Rheumatic Study Center

Los Angeles, California, 90048, United States

Location

Stanford University Medical Center-Div. of Rheumatology

Palo Alto, California, 94304, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Coeur d Alene Arthritis Clinic

Coeur d'Alene, Idaho, 83814, United States

Location

Rheumatology Associates Clinical Research

Chicago, Illinois, 60612, United States

Location

Justus J. Fiechtner MD PC

Lansing, Michigan, 48910-8595, United States

Location

The Center for Rheumatology

Albany, New York, 12206, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Benaroya Research Institute at Virginia Mason

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• 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.

  PMID: 28207896 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fontolizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark C. Genovese, MD

  Stanford University Medical Center-Div. of Rheumatology

  PRINCIPAL INVESTIGATOR

• Jerry Molitor, MD, PhD

  Benaroya Research Institute at Virginia Mason

  PRINCIPAL INVESTIGATOR

• Michael H. Schiff, MD

  Denver Arthritis Clinic

  PRINCIPAL INVESTIGATOR

• Alan Kivitz, MD

  Altoona Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Craig Wiesenhutter, MD

  Coeur d Alene Arthritis Clinic

  PRINCIPAL INVESTIGATOR

• Justus J. Fiechtner, MD

  Justus Fiechtner MD PC

  PRINCIPAL INVESTIGATOR

• Daniel Wallace, MD

  Wallace Rheumatic Study Center

  PRINCIPAL INVESTIGATOR

• Joel Kremer, MD

  The Center for Rheumatology

  PRINCIPAL INVESTIGATOR

• Robert S. Katz, MD

  Rheumatology Associates Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 24, 2006
• Study Start: December 1, 2005
• Study Completion: December 1, 2006
• Last Updated: August 5, 2008

Record last verified: 2008-08

Locations

US (9)