The University of Arizona Arthritis Center (UAAC) is at the forefront of exciting advancements in arthritis and autoimmune diseases. Clinical trials have been conducted at the UAAC for more than 20 years. The Clinical Research Unit (CRU) offers a great opportunity for individuals who wish to participate in clinical research.
The Food and Drug Administration (FDA) requires that several different types of clinical trials be performed on new medications prior to approval. Subjects may benefit from research as well as contribute to the advancement of science.
HOW CAN YOU GET INVOLVED?
The Clinical Research Unit at the UAAC is currently recruiting people who have been diagnosed with rheumatoid arthritis, systemic lupus lupus erythematosus or systemic sclerosis to participate in clinical research studies. If you are interested in learning more about research studies involving these diseases, please contact the Clinical Research Unit and speak with a study coordinator.
The Clinical Research Center general email address is ArthritisResearch@arthritis.arizona.edu and phone number is (520) 626-2655.
CLINICAL TRIALS AT THE UNIVERSITY OF ARIZONA ARTHRITIS CENTER
A telephone call to a Clinical Research Coordinator can help to determine an individual's initial eligibility. The individual is then invited to the research clinic to learn specifically what the study will entail and what is expected of him or her. A physician explains the study and all questions will be answered prior to the informed consent document being signed. The individual has the option to withdraw their consent at anytime during the study, for any reason without impact on their current medical care.
Each study has different ratios of how many people receive the investigational drug versus a placebo. All subjects participating in a clinical trial will receive close medical monitoring by a rheumatologist.
Clinical Trials and Drug Development
HOW THE ARTHRITIS CENTER BECOMES INVOLVED
- First, when a pharmaceutical company is ready to test a new drug, it searches internationally for sites best suited for the trial. The company looks for sites with experienced and qualified staff and appropriate medical facilities. After the sites are chosen, their local or regional institutional review board will review the project to safeguard the interests of the trial subjects.
- Second, the pharmaceutical company launches the study by educating the research staff who work on the clinical research project.
- Third, representatives of the pharmaceutical company visit the Arizona Arthritis Center to initiate the site and ensure that all regulatory documentation has been completed and processed. Sponsor personnel also review the project with the study coordinator and appropriate research staff.
- Lastly, when all this has been completed, recruitment for "human subjects" begins. Recruitment can happen in many ways. Rheumatologists from the community or from the Arizona Arthritis Center may refer clinic patients and local and national advertising campaigns may also be used for subject recruitment.
Early in the development of a new therapy, some subjects may receive placebo (an inactive therapy). This is done in comparison with the investigational treatment to see whether or not the investigational treatment is effective. Later, the new therapy is compared with the best treatment dose available. Finally, there are long-term extensions of, generally, one to two years to ensure the safety and effectiveness of the new medication. Many subjects who enter these trials may receive the therapy long before it is approved for the general public. The information gathered from these trials is then submitted to the FDA for approval in the United States.
For more information on clinical trials visit clinicaltrials.gov.
RHEUMATOID ARTHRITIS
Clinical Research Study
You may be able to participate in this study if you:
- Are 18 years of age or older
- Have been diagnosed with rheumatoid arthritis (RA) for at least 6 months
- Are currently taking a stable dose of methotrexate
- Still have RA symptoms despite having taken methotrexate > 3 months
- Receiving stable doses of glucocorticoids or NSAID’s > two weeks
- Are willing to comply with a schedule of medical visits and procedures
To learn more, please call 520-626-2655 or email ArthritisResearch@arthritis.arizona.edu.
rheumatoid_arthritis_consent_form.pdf
SYSTEMIC SCLEROSIS-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION
Clinical Research Study
To be considered eligible to participate in this study, you must be >18 years of age with SSc or SSC-PAH.
Qualified volunteers will receive at no cost:
- Study medication
- Study-related care from a local doctor
- Reimbursement for your time and travel
Health insurance and referrals are not required to participate.
To learn more, please call 520-626-2655 or email ArthritisResearch@arthritis.arizona.edu
systemic_sclerosis_consent_form.pdf
SYSTEMIC LUPUS ERYTHEMATOSUS
Clinical Research Study
You may be eligible to take part in the GALACELA study if you:
- Are 18-75 years of age
- Were diagnosed with SLE at least 24 weeks ago
- Have been on standard of care treatment for at least 12 weeks
- Weigh at least 88 lbs (40 kg)
- Have a BMI of 18-40
Health insurance and referrals are not required to participate.
To learn more, please call 520-626-2655 or email ArthritisResearch@arthritis.arizona.edu
systemic_lupus_erythematosus_consent_form.pdf