University of Nebraska
This is a 16-week, open-label study to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) patients. All patients will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a subject becomes intolerant to a DMARD medication the subject will be withdrawn from the study at the discretion of the investigator. Visits (prior to week 16) where withdrawal is determined to be necessary will be considered end of study. End of study data (week 16) as well as study serum will be collected. (Serum only collected on those subjects who have consented to the addendum Serum and DNA of this study). A portion of the blood collected at baseline, week 8 and week 16 with the addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. The radicals have been shown to be associated with inflammation and may correlate with the progression of RA. If this is true, then treatment with RA should decrease the levels of these radicals signaling response to treatment.
Rheumatoid Arthritis
Methotrexate
Abatacept
Adalimumab
Azathioprine
Baricitinib
Certolizumab
Etanercept
Golimumab
Hydroxychloroquine
Infliximab
Leflunomide
Minocycline
Rituximab
Sarilumab
Sulfasalazine
Tofacitinib
PHASE3
The purpose of the study is to prospectively gather information on patients with rheumatoid arthritis (RA) and their response to disease-modifying antirheumatic drugs (DMARD) therapy. Specific aims of this study are: A. To evaluate the efficacy of DMARD therapy as defined by attaining ACR 50 response after 16 weeks of therapy. B. To identify predictors of DMARD response in patients with RA. * Does the presence of certain genetic factors such as the shared epitope predict DMARD response * Does the presence of serological factors (e.g. ccp (cyclic citrullinated peptide) isotypes) predict DMARD response * Does evidence of co-morbid conditions (e.g. periodontal disease) predict DMARD response A maximum of 400 rheumatoid arthritis (RA) participants will be consented for this protocol. Investigators have examined the discriminatory characteristics of several clinical and biologic parameters in predicting treatment response (at least 50% improvement based on American College of Rheumatology criteria) in initial analyses involving 54 participants with early RA treated with methotrexate monotherapy in past Rheumatoid Arthritis Investigational Network (RAIN) clinical trials. In the initial analyses, factors showing discriminatory characteristics have included rheumatoid factor (RF) isotypes (particularly Immunoglobulin A (IgA) and Immunoglobulin M (IgM), matrix metalloproteinase (MMP)-3, human leukocyte antigen-DR isotope (HLA-DRB1) shared epitope (SE)-containing alleles, C-reactive protein, and interleukin (IL)-1. For instance, it has been found that participants with low serum concentrations of RF-IgM (\< 27 IU/ml) are more likely to be non-responders than those with higher (\> 27 IU/ml) serum concentrations (79% vs. 43%). Males and females will participate in this protocol. As RA is approximately three times more common in females, it is anticipated that a higher percentage of the study participants will be female. Participants will be \> 19 years of age (age of majority in Nebraska). RA diagnosed before the age of 19 may not have the same disease characteristics as defined by the American College of Rheumatology (ACR) criterion for RA. Pediatric participants will not be enrolled in this study. Rheumatoid arthritis occurs in all races. No enrollment restrictions have been based on race or ethnic origin.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 400 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response |
| Actual Study Start Date : | 2007-12-10 |
| Estimated Primary Completion Date : | 2027-03 |
| Estimated Study Completion Date : | 2028-03 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 19 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198