Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT03414502
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.
  • Abatacept — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Adalimumab — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Azathioprine — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Baricitinib — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Certolizumab — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Etanercept — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Golimumab — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Hydroxychloroquine — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Infliximab — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Leflunomide — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Minocycline — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Rituximab — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Sarilumab — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Sulfasalazine — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.
  • Tofacitinib — DRUG
    Starting dose may be adjusted as needed at investigator's discretion.

Study Details

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.

Key Dates

Start date
Dec 10, 2007
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methotrexate Therapy
    Participants will receive methotrexate therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Abatacept Therapy
    Participants will receive abatacept therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Adalimumab Therapy
    Participants will receive adalimumab therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Azathioprine Therapy
    Participants will receive azathioprine therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Barcitinib Therapy
    Participants will receive barcitinib therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Certolizumab Therapy
    Participants will receive certolizumab therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Etanercept Therapy
    Participants will receive etanercept therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Golimumab Therapy
    Participants will receive golimumab therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Hydroxycholoroquine Therapy
    Participants will receive hydroxychloroquine therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Infliximab Therapy
    Participants will receive infliximab therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Leflunomide Therapy
    Participants will receive leflunomide therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Minocycline Therapy
    Participants will receive minocycline therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Rituximab Therapy
    Participants will receive rituximab therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Sarilumab Therapy
    Participants will receive sarilumab therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Sulfasalazine Therapy
    Participants will receive sulfasalazine therapy for rheumatoid arthritis (RA) treatment.
  • Active Comparator: Tofacitinib Therapy
    Participants will receive tofacitinib therapy for rheumatoid arthritis (RA) treatment.

Primary Outcome Measure

Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Aimee B Schreiner, MS
[email protected]
402-559-7288
Bridget E Kramer, RN
[email protected]
402-559-7288
James R O'Dell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Nebraska Medical Center· Omaha, NE

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