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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.

Study Description
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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 Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048321


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Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
More Information
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Additional Information:
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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