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


Phase 2
18 Years
N/A
Not Enrolling
Both
Arthritis, Rheumatoid

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Mark C. Genovese, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University Medical Center-Div. of Rheumatology

Authority:

United States: Food and Drug Administration

Study ID:

ZAF-711

NCT ID:

NCT00281294

Start Date:

December 2005

Completion Date:

December 2006

Related Keywords:

  • Arthritis, Rheumatoid
  • Arthritis, Rheumatoid
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Altoona Center for Clinical ResearchDuncansville, Pennsylvania  16635
Denver Arthritis ClinicDenver, Colorado  80230
Wallace Rheumatic Study CenterLos Angeles, California  90048
Stanford University Medical Center-Div. of RheumatologyPalo Alto, California  94304
Coeur d Alene Arthritis ClinicCoeur d Alene, Idaho  83814
Rheumatology Associates Clinical ResearchChicago, Illinois  60612
Justus J. Fiechtner MD PCLansing, Michigan  48910-8595
The Center for RheumatologyAlbany, New York  12206
Benaroya Research Institute at Virginia MasonSeattle, Washington  98101