Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02919761
• Date of registration: 26/09/2016
• Prospective Registration: Yes
• Primary sponsor: Mallinckrodt
• Public title: Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: November 7, 2016
• Target sample size: 259
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02919761
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Argentina, Colombia, Mexico, Peru, Puerto Rico, United States

Contacts

• Name: Clinical Team Leader
• Affiliation: Mallinckrodt Pharmaceutical

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Placebo

Drug: Acthar Gel

Primary Outcome(s)

Part 2: Number of Participants Who Maintained Low Disease Activity by Visit [Time Frame: Week 12 to Week 24]

Part 1: Number of Participants With Low Disease Activity (LDA) by Visit [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

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

Part 1: Patient's Global Assessment of Pain by Visit [Time Frame: Baseline to Week 12]

Part 1: Physician's Global Assessment of Disease Activities by Visit [Time Frame: Baseline to Week 12]

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

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

Part 2: Patient's Global Assessment of Pain by Visit [Time Frame: Baseline, Week 12 to Week 24]

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

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

Part 2: Physician's Global Assessment of Disease Activities by Visit [Time Frame: Week 12 to Week 24]

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

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

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

Secondary ID(s)

MNK14294063

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02919761