Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Veena K Ranganath(ucla)

Description

Summary

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.

Official Title

Use of Acthar in Rheumatoid Arthritis Related Flares

Details

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.

Keywords

Rheumatoid Arthritis (RA) Musculoskeletal ultrasound (MSUS) Arthritis Arthritis, Rheumatoid Adrenocorticotropic Hormone Acthar

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient must meet 1987 ACR criteria
  2. Age > 18 years of age
  3. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2
  4. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
  5. Stable prednisone <10mg or equivalent
  6. Power Doppler score of >=10

You CAN'T join if...

  1. Prior treatment with Acthar in the past 2mos
  2. Meet one of the above RA flare requirements
  3. Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Location

  • UCLA David Geffen School of Medicine, Division of Rheumatology accepting new patients
    Los Angeles California 90095 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dr. Veena Ranganath
ID
NCT02541955
Phase
Phase 4
Study Type
Interventional
Last Updated