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

NCT ID: NCT01966718

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Repository corticotropin injection

Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks

Group Type: EXPERIMENTAL

Repository corticotropin injection

Intervention Type: DRUG

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

Interventions

Repository corticotropin injection

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

Intervention Type: DRUG

Other Intervention Names

H. P. Acthar Gel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Treatment Center, Maryland

OTHER

Sponsor Role: lead

Responsible Party

Nathan Wei, MD, FACP, FACR:

Nathan Wei, MD, FACP, FACR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Nathan Wei, MD dba Arthritis Treatment Center, Frederick, MD 21702 USA

Locations

Arthritis Treatment Center

Frederick, Maryland, United States

Countries

United States

Other Identifiers

ATC 005

Identifier Type: -

Identifier Source: org_study_id