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A Multicenter, 2 Part Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Participants With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02919761
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Acthar Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label
Acthar 1 mL (80 U) 2x/week
Drug: Acthar
Experimental: Acthar
Acthar 1 mL (80 U) 2x/week
Drug: Acthar
Placebo Comparator: Placebo
Placebo 1 mL
Drug: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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. 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.

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): NCT02919761


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Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Matthew Barton Mallinckrodt Pharmaceutical

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02919761     History of Changes
Other Study ID Numbers: MNK14294063
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: January 2019

Keywords provided by Mallinckrodt:
persistant disease activity

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