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ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
This study has been completed.
First Received: October 29, 2002   Last Updated: October 15, 2007   History of Changes
Sponsor: Isis Pharmaceuticals
Information provided by: Isis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00048321
  Purpose

ISIS 104838 is an antisense oligonucleotide drug that reduces the production of a specific protein called tumor necrosis factor (TNF-alpha), a substance that contributes to joint pain and swelling in rheumatoid arthritis. ISIS 104838 works by blocking TNF-alpha messenger RNA, the "instruction" molecule that is required for the production of TNF-alpha protein. This trial will assess the safety and efficacy of ISIS 1048383 by subcutaneous injection, administered by 3 different dosing regimens for 3 months, versus placebo. Approximately 160 TNF-alpha inhibitor-naïve rheumatoid arthritis patients will be evaluated at 32 sites in the U.S. and Canada.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: ISIS 104838
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: ISIS 104838-CS7, A Double-Blind, Placebo-Controlled, Randomized Trial of the Safety, Efficacy and Pharmacokinetic Profile of ISIS 104838 (TNF-Alpha Antisense Oligonucleotide) Subcutaneous Injections in Active Rheumatoid Arthritis Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Rheumatoid Arthritis
Drug Information available for: ISIS 104838 Tumor Necrosis Factors
U.S. FDA Resources

Further study details as provided by Isis Pharmaceuticals:

Estimated Enrollment: 160
Study Start Date: January 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age >/= 18 years.
  2. Rheumatoid arthritis for >/= 6 months.
  3. Active disease as defined by >/= 6 swollen and >/= 9 tender joints, AND an abnormal C-reactive protein or Westergren Erythrocyte Sedimentation Rate lab test, OR Morning Stiffness >/= 1 hour.
  4. Use of at least one DMARD, and ability to discontinue any current DMARD.

Exclusion Criteria

  1. Onset of rheumatoid arthritis before the 16th birthday.
  2. Wheelchair or bed-bound functional level.
  3. No previous infliximab or etanercept treatment, or investigational therapy (not placebo) with other TNF-alpha inhibitors.
  4. Prednisone > 10 mg per day or more than one nonsteroidal anti-inflammatory drug.
  5. Patients with an active infection, a history of tuberculosis, multiple sclerosis, other poorly controlled medical illness, or a malignancy within the last 5 years.
  6. Patients who require intravenous heparin therapy or with a history of a bleeding problem.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048321

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Paradise Valley, Arizona, United States
United States, California
Rancho Cucamonga, California, United States
Los Angeles, California, United States
United States, Florida
Sarasota, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Ft. Lauderdale, Florida, United States
United States, Georgia
Decatur, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maryland
Greenbelt, Maryland, United States
United States, Massachusetts
Fall River, Massachusetts, United States
United States, Michigan
Lansing, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, Ohio
Mayfield Village, Ohio, United States
United States, Pennsylvania
Willow Grove, Pennsylvania, United States
Duncansville, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Lubbock, Texas, United States
Carrollton, Texas, United States
Amarillo, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
Canada, Alberta
Edmonton, Alberta, Canada
Calgary, Alberta, Canada
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Ottawa, Ontario, Canada
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

Additional Information:
Type "ISIS 104838" in search box  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: ISIS 104838-CS7
Study First Received: October 29, 2002
Last Updated: October 15, 2007
ClinicalTrials.gov Identifier: NCT00048321     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases
 Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009



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