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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ISIS 104838
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 29, 2002
Last Updated
December 1, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00048321
Brief Title
ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 1, 2002 (Actual)
Primary Completion Date
February 1, 2003 (Actual)
Study Completion Date
February 1, 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ISIS 104838

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Paradise Valley
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Rancho Cucamonga
State/Province
California
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Decatur
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Greenbelt
State/Province
Maryland
Country
United States
City
Fall River
State/Province
Massachusetts
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Mayfield
State/Province
Ohio
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Willow Grove
State/Province
Pennsylvania
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Carrollton
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35976085
Citation
Burel SA, Machemer T, Baker BF, Kwoh TJ, Paz S, Younis H, Henry SP. Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. Nucleic Acid Ther. 2022 Dec;32(6):457-472. doi: 10.1089/nat.2022.0033. Epub 2022 Aug 17.
Results Reference
derived
Links:
URL
http://www.centerwatch.com
Description
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ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

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