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OpenTrials
Completed

NCT Number: NCT00048321

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/= 18 years.
  • Rheumatoid arthritis for >/= 6 months.
  • 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.
  • Use of at least one DMARD, and ability to discontinue any current DMARD.

Exclusion criteria

  • Onset of rheumatoid arthritis before the 16th birthday.
  • Wheelchair or bed-bound functional level.
  • No previous infliximab or etanercept treatment, or investigational therapy (not placebo) with other TNF-alpha inhibitors.
  • Prednisone > 10 mg per day or more than one nonsteroidal anti-inflammatory drug.
  • Patients with an active infection, a history of tuberculosis, multiple sclerosis, other poorly controlled medical illness, or a malignancy within the last 5 years.
  • Patients who require intravenous heparin therapy or with a history of a bleeding problem.

Treatment and study plan

ISIS 104838

Drug

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 31, 2002
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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