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Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541955
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE July 20, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Ultrasound Power Doppler Score [ 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.
  • DAS28 [ Time Frame: Baseline to 2 Weeks ]
    DAS28 will be calculated. The change in the scores will be analyzed between the two groups.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • Ultrasound Power Doppler Score [ Time Frame: Baseline to 4 Weeks ]
    Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.
  • DAS28 [ Time Frame: Baseline to 4 Weeks ]
    DAS28 will be calculated. The change in the scores will be analyzed between the two groups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Ultrasound Grey Scale Synovial Hypertrophy score [ 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.
  • HAQ-DI [ 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • Ultrasound Grey Scale Synovial Hypertrophy score [ Time Frame: Baseline to 4 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.
  • HAQ-DI [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
Official Title  ICMJE Use of Acthar in Rheumatoid Arthritis Related Flares
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Rheumatoid Arthritis (RA)
Intervention  ICMJE Drug: Acthar
Injections will be self administered
Study Arms  ICMJE
  • Active Comparator: 40 Units
    40 units of Acthar per week
    Intervention: Drug: Acthar
  • Active Comparator: 80 Units
    80 units of Acthar twice per week
    Intervention: Drug: Acthar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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

Exclusion Criteria:

  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Veena K Rangantah, M.D., M.S. 310-825-3061 vranganath@mednet.ucla.edu
Contact: Bal-lan Yen 310-206-4112 byen@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02541955
Other Study ID Numbers  ICMJE Acthar in Rheumatoid Arthritis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Veena Ranganath, University of California, Los Angeles
Study Sponsor  ICMJE Dr. Veena Ranganath
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Veena K Ranganath, M.D., M.S. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP