RECRUITING

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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, 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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.

Official Title

Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response

Quick Facts

Study Start:2007-12-10
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03414502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria
  2. * Morning stiffness for at least 1 hour for at least 6 weeks
  3. * Swelling of 3 or more joints for at least 6 weeks
  4. * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks
  5. * Symmetric joint swelling
  6. * Hand x-rays with erosions or bony decalcifications
  7. * RA nodules
  8. * Rheumatoid factor (RF) positive
  9. * \>19 yrs old at RA diagnosis
  10. * Active disease with at least 1 swollen joint
  11. * Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)
  12. * If on other DMARDS, must be on stable dose for ≥ 6 wks
  13. * If on glucocorticoids, must be on stable dose for 2 wks (\< 10mg of Prednisone/day or equivalent)
  14. * Able to adhere to study visit schedule: enrollment (8 wks \& 16 wks +/- 2 wks)
  15. * Hemoglobin (Hgb) \> 9g/dl
  16. * Platelets \>100
  17. * Creatinine \<1.6
  18. * Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit
  19. * Albumin up to 1.0 g/dL below lower limit of normal
  1. * Pregnant or breastfeeding women
  2. * Men and women of child bearing potential unwilling to practice effective method of contraception

Contacts and Locations

Study Contact

Aimee B Schreiner, MS
CONTACT
402-559-4873
aischreiner@unmc.edu

Principal Investigator

James R O'Dell, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • James R O'Dell, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-12-10
Study Completion Date2028-03

Study Record Updates

Study Start Date2007-12-10
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Methotrexate
  • DMARD

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis