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CompletedNCT00048321Updated Dec 5, 2022

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

A Phase 2 interventional study of ISIS 104838 in Rheumatoid Arthritis, sponsored by Ionis Pharmaceuticals, Inc.. Completed at 31 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Ionis Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2002, registered Oct 2002).
Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 160 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Ionis Pharmaceuticals, Inc. is the lead sponsor of 118 studies on the registry; 10 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 22 (45%) have results posted.

Browse Ionis Pharmaceuticals, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
160 participants

Interventions

  • DrugISIS 104838
06

Study locations

31 sites
  • Birmingham, Alabama, United States
  • Paradise Valley, Arizona, United States
  • Los Angeles, California, United States
  • Rancho Cucamonga, California, United States
  • Fort Lauderdale, Florida, United States
  • Palm Harbor, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Decatur, Georgia, United States
  • Chicago, Illinois, United States
  • Wichita, Kansas, United States
  • Louisville, Kentucky, United States
  • Greenbelt, Maryland, United States
  • Fall River, Massachusetts, United States
  • Lansing, Michigan, United States
  • St Louis, Missouri, United States
  • Albuquerque, New Mexico, United States
  • Mayfield, Ohio, United States
  • Duncansville, Pennsylvania, United States
  • Willow Grove, Pennsylvania, United States
  • Amarillo, Texas, United States
  • Carrollton, Texas, United States
  • Dallas, Texas, United States
  • Lubbock, Texas, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Victoria, British Columbia, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
07

References and documents

Publications

  • 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. PubMed 35976085 ↗
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2002 to primary completion in Feb 2003, 13 months.

Of 114 industry-sponsored phase 2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 24. This study's 13 months is below that.

Counting every sponsor, half of 154 studies reached it within 18 months; a quarter within 13 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2002
First posted
Oct 31, 2002
StartActual
Jan 1, 2002
Primary completionActual
Feb 1, 2003
CompletionActual
Feb 1, 2003
Last update
Dec 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00048321
Lead sponsor
Ionis Pharmaceuticals, Inc.
First posted
Oct 31, 2002
Start date
Jan 1, 2002
Primary completion
Feb 1, 2003
Completion
Feb 1, 2003
Last update
Dec 5, 2022
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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