Status:
RECRUITING
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
Lead Sponsor:
University of Nebraska
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria
- Morning stiffness for at least 1 hour for at least 6 weeks
- Swelling of 3 or more joints for at least 6 weeks
- Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks
- Symmetric joint swelling
- Hand x-rays with erosions or bony decalcifications
- RA nodules
- Rheumatoid factor (RF) positive
- \>19 yrs old at RA diagnosis
- Active disease with at least 1 swollen joint
- Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)
- If on other DMARDS, must be on stable dose for ≥ 6 wks
- If on glucocorticoids, must be on stable dose for 2 wks (\< 10mg of Prednisone/day or equivalent)
- Able to adhere to study visit schedule: enrollment (8 wks \& 16 wks +/- 2 wks)
- Hemoglobin (Hgb) \> 9g/dl
- Platelets \>100
- Creatinine \<1.6
- Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit
- Albumin up to 1.0 g/dL below lower limit of normal
- EXCLUSION CRITERIA:
- Pregnant or breastfeeding women
- Men and women of child bearing potential unwilling to practice effective method of contraception
Exclusion
Key Trial Info
Start Date :
December 10 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03414502
Start Date
December 10 2007
End Date
March 1 2029
Last Update
August 8 2025
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198