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Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

NCT02919761 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2020-03-31

Study results available
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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.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Acthar Gel

80 Units Acthar Gel per 1 mL for subcutaneous injection

DRUG

Placebo

Matching placebo 1 mL for subcutaneous injection

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-07
Primary Completion
2018-10-17
Completion
2019-02-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Mexico
  • Peru
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919761 on ClinicalTrials.gov