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Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919761
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE September 29, 2016
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE November 7, 2016
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
Proportion of participants with Disease Activity Score with 28 joint count and Erythrocyte Sedimentation Rate (DAS28-ESR) [ Time Frame: 12 Weeks ]
Proportion of participants with DAS28-ESR <3.2 at Week 12
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
Proportion of subjects with Disease Activity Score with 28 joint count and Erythrocyte Sedimentation Rate (DAS28-ESR) [ Time Frame: 12 Weeks ]
Proportion of subjects with DAS28-ESR <3.2 at Week 12
Change History Complete list of historical versions of study NCT02919761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
Proportion of participants who maintained DAS28-ESR [ Time Frame: 24 Weeks ]
Proportion of participants with Low Disease Activity as defined by DAS28-ESR <3.2 at Week 24
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
Proportion of subjects who maintained DAS28-ESR [ Time Frame: 24 Weeks ]
Proportion of subjects with Low Disease Activity as defined by DAS28-ESR <3.2 at Week 24
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
Official Title  ICMJE A Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease
Brief Summary 2 part multicenter study to examine the effect of Acthar in adult participants with rheumatoid arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar for 12 weeks. After 12 weeks of treatment with Acthar, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar or matching placebo for an additional 12 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Acthar
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Open Label
    Acthar 1 mL (80 U) 2x/week
    Intervention: Drug: Acthar
  • Experimental: Acthar
    Acthar 1 mL (80 U) 2x/week
    Intervention: Drug: Acthar
  • Placebo Comparator: Placebo
    Placebo 1 mL
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
259
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2016)
232
Actual Study Completion Date  ICMJE March 20, 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants must meet criteria for rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening.
  2. Participants must have persistently active rheumatoid arthritis defined as DAS 28-ESR > 3.2 at screening.
  3. Participants must have been on a corticosteroid 12 weeks prior to screening, with a stable dose of 5-10 mg prednisone (or prednisone equivalent) for 4 weeks prior to screening.
  4. Participants must have been on either a non-biologic or biologic treatment in the 12 weeks prior to screening.

Exclusion Criteria:

  1. Participants cannot have used intra-articular steroids within 14 days of the screening visit.
  2. Participants cannot have any known contraindication to Acthar.
  3. Participants cannot have Type 1 or Type 2 diabetes.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Mexico,   Peru,   Puerto Rico,   United States
Removed Location Countries Colombia
 
Administrative Information
NCT Number  ICMJE NCT02919761
Other Study ID Numbers  ICMJE MNK14294063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mallinckrodt
Study Sponsor  ICMJE Mallinckrodt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Team Leader Mallinckrodt Pharmaceutical
PRS Account Mallinckrodt
Verification Date January 2019

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