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

This study has been completed.

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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind 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

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

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

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012