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ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048321
Recruitment Status : Completed
First Posted : October 31, 2002
Last Update Posted : October 17, 2007
Sponsor:
Information provided by:
Ionis Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ISIS 104838 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2002

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048321


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Paradise Valley, Arizona, United States
United States, California
Los Angeles, California, United States
Rancho Cucamonga, California, United States
United States, Florida
Ft. Lauderdale, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
Tampa, 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
Duncansville, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
United States, Texas
Amarillo, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Lubbock, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Seattle, Washington, United States
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Additional Information:
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ClinicalTrials.gov Identifier: NCT00048321    
Other Study ID Numbers: ISIS 104838-CS7
First Posted: October 31, 2002    Key Record Dates
Last Update Posted: October 17, 2007
Last Verified: October 2007
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases