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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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    Page 1 of 1 (1 locations)

    1

    University of Nebraska Medical Center

    Omaha, Nebraska, United States, 68198