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NCT03414502 · ClinicalTrials.gov registry record · Phase 3
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
A Phase 3 study of Rheumatoid Arthritis, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT03414502 is a Phase 3 study of Rheumatoid Arthritis that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 400 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03414502, a Phase 3 study of Rheumatoid Arthritis, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified. This study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.
Conditions Studied
Interventions
- DRUG Abatacept
- DRUG Adalimumab
- DRUG Baricitinib
- DRUG Methotrexate
- DRUG Azathioprine
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2007-12-10 |
| Est. Completion | 2029-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03414502
The ClinicalTrials.gov registry entry for NCT03414502 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (91% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions - of which Abatacept is the first listed.
NCT03414502 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT03414502 about?
NCT03414502 is a clinical study titled "Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response". Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs...
What is the current status of trial NCT03414502?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2007-12-10. Estimated completion is 2029-03.
What conditions does trial NCT03414502 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT03414502?
The interventions under investigation include: Abatacept (DRUG), Adalimumab (DRUG), Baricitinib (DRUG), Methotrexate (DRUG), Azathioprine (DRUG).
Who is sponsoring clinical trial NCT03414502?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03414502 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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