Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

Phase 4CompletedNCT01966718

Arthritis Treatment Center, Maryland8 enrolled

Overview

It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.

Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

Repository corticotropin injectionDRUG

An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Rheumatoid arthritis of at least 2 years duration * On at least third biologic with a different mechanism of action for at least 12 weeks * Active disease as defined by at least 6 tender and 6 swollen joints * Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal * Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks Exclusion Criteria: * Prior treatment with Acthar Gel * History of intolerance or allergy to glucocorticoids * Unstable diabetes * Active infection

Locations (1)

Arthritis Treatment Center

Frederick, Maryland, United States

Outcomes

Primary Outcomes

Change From Baseline in the Ritchey-Camp Articular Index

Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.

Time frame: From baseline to week 16

Change From Baseline in the 20-item Health Assessment Questionnaire Score

Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.

Time frame: From baseline to week 16

Secondary Outcomes

Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)

ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased

Time frame: From baseline to week 16

Change From Baseline in the C-Reactive Protein (CRP) Level

CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.

Time frame: From baseline to week 16

Data from ClinicalTrials.gov

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