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

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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

Study Type : Interventional  (Clinical Trial)
Estimated 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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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


  Show 31 Study Locations
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.

Additional Information:
ClinicalTrials.gov Identifier: NCT00048321     History of Changes
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:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases