Summary:
This is a research study of a new investigational medication to determine if it may improve treatment of rheumatoid arthritis (RA).
SUMMARY:
- Up to $4050.00 in compensation
- 12 week study
- Patients with RA taking methotrexate
- 17 visits to our clinic
- 2 periods of overnight stays at our clinic
Description:
This is a 12 week study for patients who have been diagnosed with rheumatoid arthritis for at least 3 months, have been taking methotrexate for at least 3 months and are not taking other specific medications.
Number of Visits:
The study has 17 outpatient visits and two inpatient visit periods of staying at the clinic for 3 or 4 days each.
Compensation:
Participants may be compensated up to $4050.00 for their time and travel for completing all visits.
During the Study:
The investigational medication will be given as a subcutaneous injection weekly at the clinic for 8 weeks. All study-related care and investigational medication will be provided to participants at no cost.
The study will assesses joint pain, joint swelling, how RA effects participant’s lives and the blood level of investigational medication at different times during the study.
The study involves a screening visit where patients will be given an opportunity to review information about the study and decide if they want to participate in the study. The decision about whether to participate does not need to be made at the screening visit. Patients can take the study information home with them to discuss it with others before deciding if they want to participate.
Patients that decide to participate and are eligible will continue the screening which consists of having the study team obtain urine and blood samples, perform a study-related physical exam by the study physician, obtain an EKG and vital signs and review the patient's medical history. After the screening results have been reviewed by the study team, eligible patients may participate in the study which consists of 17 outpatient visits over 12 weeks and two inpatient visit periods of 3 or 4 days each.
Each outpatient visit will take about 2 hours. At outpatient visits a study physician will evaluate the participant's RA and the study team will assess the effect RA has on the participant's life through questionnaires, and perform some of the same procedures that were done at the screening visit. During the inpatient visits participants will stay at the clinic overnight for 2 nights at the beginning of the study and 3 nights near the end of the study. On these visit days the study team will obtain samples to determine the level of investigational medication in participant's blood and perform some of the same procedures that were performed during the screening visit.