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

Rheumatoid Arthritis Clinical Trial

Official title:

Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01966718
• Other study ID #: ATC 005
• Status: Recruiting
• Phase: Phase 4
• First received: October 14, 2013
• Last updated: July 31, 2015
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2015
• Source: Arthritis Treatment Center, Maryland
• Contact: Michelle Grimm
• Phone: 301-624-1164
• Email: mgrimm[@]arthritistreatmentcenter.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Arthritis Treatment Center	Frederick	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Arthritis Treatment Center, Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Ritchey-Camp Articular Index	A formal count of 68 joints will be conducted to assess for tenderness and/or swelling at each study visit. Changes from baseline to final study visit at week 16 will be evaluated.	From baseline to week 16, measured at 2-6 week intervals	No
Primary	Change from baseline in the 20-item Health Assessment Questionnaire score	Subjects will be asked to complete the 20-item Health Assessment Questionnaire at each study visit. Changes from baseline to final study visit at week 16 will be evaluated.	From baseline to week 16, measured in 2-6 week intervals	No
Secondary	Change from baseline in the erythrocyte sedimentation rate (ESR)	ESR will be obtained as part of the lab work during each study visit. Changes from baseline to the final study visit at week 16 will be evaluated.	From baseline to week 16, measured at 2-6 week intervals	No
Secondary	Change from baseline in the C-Reactive protein (CRP) level	CRP level will be obtained as part of the lab work during each study visit. Changes from baseline to the final study visit at week 16 will be evaluated.	From baseline to week 16, measured in 2-6 week intervals	No