UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, 90095, United States
NCT Number: NCT02541955
This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Los Angeles, California, 90095, United States
Participants with active RA flair will be assigned to take on one of two Acthar doses, either 40 units per week or 80 units twice a week. Both arms will be taking the drug for 4 weeks. Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit. During these visits the following information will be collected: MSUS of joints, DAS28, Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID3) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Participants will also be asked to fill out a questionnaire about their health status.
Efficacy of Acthar to decrease evidence of MSUS synovitis and disease activity measures will be analyzed using the above mentioned instruments, as well as Acthar's ability to prevent the necessity to change patients' RA treatment regimen.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injections will be self administered
Other names: Repository corticotropin injection
Time frame: Baseline to 2 Weeks
Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.
Time frame: Baseline to 2 Weeks
DAS28 will be calculated. The change in the scores will be analyzed between the two groups.
Time frame: Baseline to 2 Weeks
Using Ultrasound a measure of Grey Scale Synovial Hypertrophy will be calculated. The change in the scores will be analyzed between the two groups.
Time frame: Baseline to 4 Weeks
Self-administered HAQ-DI summary score will be calculated. The change in the scores will be analyzed between the two groups
Veena Ranganath, MD, MS
Other
Use of Acthar in Rheumatoid Arthritis Related Flares
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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