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Trial record 1 of 6 for:    acthar rheumatoid arthritis mallinckrodt
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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
Results First Posted : March 23, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:

This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.

Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.

Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.

A single participant might be involved in the trial for as many as 32 weeks.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1: Single Group; Part 2: Parallel
Masking: Double (Participant, Investigator)
Masking Description: Part 1: Open Label ; Part 2: Double-blind
Primary Purpose: Treatment
Official Title: A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : February 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: All Enrolled Participants
All participants receive Acthar Gel 1 mL twice weekly for 12 weeks
Drug: Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
Other Names:
  • Acthar
  • H.P. Acthar Gel

Experimental: Part 2: Acthar Gel
Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
Drug: Acthar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
Other Names:
  • Acthar
  • H.P. Acthar Gel

Placebo Comparator: Part 2: Placebo
Participants receive Placebo 1 mL twice weekly for an additional 12 weeks
Drug: Placebo
Matching placebo 1 mL for subcutaneous injection
Other Name: Matching Placebo




Primary Outcome Measures :
  1. Part 1: Number of Participants With Low Disease Activity (LDA) by Visit [ Time Frame: Baseline to Week 12 ]
    LDA is defined as DAS28 <3.2.

  2. Part 2: Number of Participants Who Maintained Low Disease Activity by Visit [ Time Frame: Week 12 to Week 24 ]
    Low disease activity is defined as DAS28 <3.2.


Secondary Outcome Measures :
  1. Part 1: Swollen Joint Count by Visit [ Time Frame: Baseline to Week 12 ]

    The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)

    The DAS28 is a composite score derived from the following assessments:

    • Swollen Joint Count
    • Tender Joint Count
    • Patient's Global Health
    • Erythrocyte Sedimentation Rate

  2. Part 2: Swollen Joint Count by Visit During Part 2 [ Time Frame: Baseline, Week 12 to Week 24 ]

    The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)

    The DAS28 is a composite score derived from the following assessments:

    • Swollen Joint Count
    • Tender Joint Count
    • Patient's Global Health
    • Erythrocyte Sedimentation Rate

  3. Part 1: Tender Joint Count by Visit [ Time Frame: Baseline to Week 12 ]

    The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)

    The DAS28 is a composite score derived from the following assessments:

    • Swollen Joint Count
    • Tender Joint Count
    • Patient's Global Health
    • Erythrocyte Sedimentation Rate

  4. Part 2: Tender Joint Count by Visit [ Time Frame: Baseline, Week 12 to Week 24 ]

    The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)

    The DAS28 is a composite score derived from the following assessments:

    • Swollen Joint Count
    • Tender Joint Count
    • Patient's Global Health
    • Erythrocyte Sedimentation Rate

  5. Part 1: Patient-Reported General Health by Visit [ Time Frame: Baseline to Week 12 ]

    Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.

    A lower score indicates better general health.


  6. Part 2: Patient-Reported General Health by Visit [ Time Frame: Baseline, Week 12 to Week 24 ]

    Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.

    A lower score indicates better general health.


  7. Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit [ Time Frame: Baseline to Week 12 ]

    The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.

    The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).

    The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.

    The ESR is a common test for inflammation and used to derive the DAS28.

    The DAS28 is a composite score derived from the following assessments:

    • Swollen Joint Count
    • Tender Joint Count
    • Patient's Global Health
    • Erythrocyte Sedimentation Rate

  8. Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit [ Time Frame: Baseline, Week 12 to Week 24 ]

    The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.

    The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).

    The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.

    The ESR is a common test for inflammation and used to derive the DAS28.

    The DAS28 is a composite score derived from the following assessments:

    • Swollen Joint Count
    • Tender Joint Count
    • Patient's Global Health
    • Erythrocyte Sedimentation Rate

  9. Part 1: Patient's Global Assessment of Pain by Visit [ Time Frame: Baseline to Week 12 ]
    Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.

  10. Part 2: Patient's Global Assessment of Pain by Visit [ Time Frame: Baseline, Week 12 to Week 24 ]
    Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.

  11. Part 1: Physician's Global Assessment of Disease Activities by Visit [ Time Frame: Baseline to Week 12 ]
    The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.

  12. Part 2: Physician's Global Assessment of Disease Activities by Visit [ Time Frame: Week 12 to Week 24 ]
    The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.



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:

  • Male or nonpregnant, nonlactating female subjects
  • Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
  • Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
  • Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
  • May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration

Exclusion Criteria:

  • Has current rheumatoid disease or inflammatory joint disease other than RA
  • Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
  • Has taken B-cell mediated therapies in the 6 months prior to screening
  • Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
  • Has history of Type 1 or Type 2 diabetes
  • Has any clinically significant infection

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


Locations
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Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Leader Mallinckrodt Pharmaceutical
  Study Documents (Full-Text)

Documents provided by Mallinckrodt:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02919761    
Other Study ID Numbers: MNK14294063
First Posted: September 29, 2016    Key Record Dates
Results First Posted: March 23, 2020
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mallinckrodt:
Persistent 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