Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska
About this trial
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 If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator.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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant or breastfeeding women
Men and women of child bearing potential unwilling to practice effective method of contraception
Trial design
Design model
Parallel
Treatments tested in this trial
Methotrexate
DrugStarting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.
Abatacept
DrugStarting dose may be adjusted as needed at investigator's discretion.
Adalimumab
DrugStarting dose may be adjusted as needed at investigator's discretion.
Azathioprine
DrugStarting dose may be adjusted as needed at investigator's discretion.
Baricitinib
DrugStarting dose may be adjusted as needed at investigator's discretion.
Certolizumab
DrugStarting dose may be adjusted as needed at investigator's discretion.
Etanercept
DrugStarting dose may be adjusted as needed at investigator's discretion.
Golimumab
DrugStarting dose may be adjusted as needed at investigator's discretion.
Hydroxychloroquine
DrugStarting dose may be adjusted as needed at investigator's discretion.
Infliximab
DrugStarting dose may be adjusted as needed at investigator's discretion.
Leflunomide
DrugStarting dose may be adjusted as needed at investigator's discretion.
Minocycline
DrugStarting dose may be adjusted as needed at investigator's discretion.
Rituximab
DrugStarting dose may be adjusted as needed at investigator's discretion.
Sarilumab
DrugStarting dose may be adjusted as needed at investigator's discretion.
Sulfasalazine
DrugStarting dose may be adjusted as needed at investigator's discretion.
Tofacitinib
DrugStarting dose may be adjusted as needed at investigator's discretion.
Treatment groups
400 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Methotrexate TherapyActive comparator 1 intervention
Group B: Abatacept TherapyActive comparator 1 intervention
Group C: Adalimumab TherapyActive comparator 1 intervention
Group D: Azathioprine TherapyActive comparator 1 intervention
Group E: Barcitinib TherapyActive comparator 1 intervention
Group F: Certolizumab TherapyActive comparator 1 intervention
Group G: Etanercept TherapyActive comparator 1 intervention
Group H: Golimumab TherapyActive comparator 1 intervention
Group I: Hydroxycholoroquine TherapyActive comparator 1 intervention
Group J: Infliximab TherapyActive comparator 1 intervention
Group K: Leflunomide TherapyActive comparator 1 intervention
Group L: Minocycline TherapyActive comparator 1 intervention
Group M: Rituximab TherapyActive comparator 1 intervention
Group N: Sarilumab TherapyActive comparator 1 intervention
Group O: Sulfasalazine TherapyActive comparator 1 intervention
Group P: Tofacitinib TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis
The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame
16 weeksSecondary outcomes
1
Genetic factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have genetic factors, such as the shared epitope, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame
16 weeks2
Serological Factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have serological factors, such as cyclic citrullinated peptide (CCP) isotypes, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame
16 weeks3
Co-morbid Conditions as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have co-morbid conditions, such as periodontal disease, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame
16 weeksSponsors and contacts
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Source ClinicalTrials.gov