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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

ISIS 104838-CS7

NCT ID:

NCT00048321

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Kansas City, Kansas  66160
Albuquerque, New Mexico  87131-5636
Baltimore, Maryland  21287
Boston, Massachusetts