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Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

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ClinicalTrials.gov Identifier: NCT02541955
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: Acthar Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Acthar in Rheumatoid Arthritis Related Flares
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 40 Units
40 units of Acthar per week
Drug: Acthar
Injections will be self administered

Active Comparator: 80 Units
80 units of Acthar twice per week
Drug: Acthar
Injections will be self administered




Primary Outcome Measures :
  1. 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.

  2. DAS28 [ Time Frame: Baseline to 2 Weeks ]
    DAS28 will be calculated. The change in the scores will be analyzed between the two groups.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541955


Contacts
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

Locations
United States, California
UCLA David Geffen School of Medicine, Division of Rheumatology Recruiting
Los Angeles, California, United States, 90095
Contact: Veena K Ranganath, M.D.    310-825-6301    vranganath@mednet.ucla.edu   
Principal Investigator: Veena K Ranganath, M.D.         
Sub-Investigator: Suzanne Kafaja, M.D.         
Sponsors and Collaborators
Dr. Veena Ranganath
Investigators
Principal Investigator: Veena K Ranganath, M.D., M.S. University of California, Los Angeles

Responsible Party: Dr. Veena Ranganath, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02541955     History of Changes
Other Study ID Numbers: Acthar in Rheumatoid Arthritis
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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

Keywords provided by Dr. Veena Ranganath, University of California, Los Angeles:
Rheumatoid arthritis (RA)
Musculoskeletal ultrasound (MSUS)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs