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Completed

NCT Number: NCT02919761

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aprillus Asistencia e Investigación, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acthar Gel

Drug

80 Units Acthar Gel per 1 mL for subcutaneous injection

Other names: Acthar, H.P. Acthar Gel

Placebo

Drug

Matching placebo 1 mL for subcutaneous injection

Other names: Matching Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 29, 2016
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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