Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||19 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Nebraska|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|James R O'Dell, MD|
|Principal Investigator Affiliation||University of Nebraska|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
The purpose of the study is to gather, in a prospective manner, information on patients with early rheumatoid arthritis and their response to methotrexate therapy. Specific aims of this study are:
Other: Single arm Methotrexate
This study is a 16-week, open-label study designed to identify the subset of RA patients that respond to methotrexate monotherapy. All patients will receive methotrexate at a starting dose of 15 mg once weekly plus folic acid 1 mg daily. If a patient is not in remission by 8 weeks, then the dose will be escalated as tolerated to 20 mg once weekly. Both oral and injectable methotrexate are acceptable. If the patient is unable to tolerate the Methotrexate at 15 mg, it is allowed to titrate the dose as tolerated as long as patient remains on Methotrexate.
Drug: - Methotrexate
Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg. daily.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.