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

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ClinicalTrials.gov Identifier: NCT02919761
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
2 part multicenter study to examine the effect of Acthar in adult subjects with rheumatoid arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in which all eligible subjects receive Acthar for 12 weeks. After 12 weeks of treatment with Acthar, subjects will be evaluated for treatment response using the DAS28-ESR. Subjects 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 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 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


Secondary Outcome Measures :
  1. 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



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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. Subjects must meet criteria for rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening.
  2. Subjects must have persistently active rheumatoid arthritis defined as DAS 28-ESR > 3.2 at screening.
  3. Subjects 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. Subjects must have been on either a non-biologic or biologic treatment in the 12 weeks prior to screening.

Exclusion Criteria:

  1. Subjects cannot have used intra-articular steroids within 14 days of the screening visit.
  2. Subjects cannot have any known contraindication to Acthar.
  3. Subjects 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


Contacts
Contact: Roman Bilyk 800-556-3314 clinicaltrials@mnk.com

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

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: May 28, 2018
Last Verified: May 2018

Keywords provided by Mallinckrodt:
persistant disease activity

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