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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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: Acthar Gel
Drug: Placebo
Primary Outcome(s)
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit [Time Frame: Baseline to Week 12]
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit [Time Frame: Week 12 to Week 24]
Secondary Outcome(s)
Part 1: Erythrocyte Sedimentation Rate (ESR) 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: Patient-Reported General Health 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 1: Swollen Joint Count by Visit [Time Frame: Baseline to Week 12]
Part 1: Tender Joint Count by Visit [Time Frame: Baseline to Week 12]
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit [Time Frame: Baseline, Week 12 to Week 24]
Part 2: Patient's Global Assessment of Pain by Visit [Time Frame: Baseline, Week 12 to Week 24]
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: Swollen Joint Count by Visit During Part 2 [Time Frame: Baseline, Week 12 to Week 24]
Part 2: Tender Joint Count 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
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 23/03/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02919761
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