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

This study has been completed.

First Received: October 29, 2002 Last Updated: October 15, 2007 History of Changes

Sponsored by:	Isis Pharmaceuticals
Information provided by:	Isis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00048321

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: ISIS 104838	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Rheumatoid Arthritis

Drug Information available for: ISIS 104838 Tumor Necrosis Factors

U.S. FDA Resources

Further study details as provided by Isis Pharmaceuticals:

Estimated Enrollment:	160
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048321

Show 31 Study Locations

Sponsors and Collaborators

Isis Pharmaceuticals

More Information

Additional Information:

Type "ISIS 104838" in search box This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ISIS 104838-CS7
Study First Received:	October 29, 2002
Last Updated:	October 15, 2007
ClinicalTrials.gov Identifier:	NCT00048321 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 02, 2009