ACTH Gel Therapy in Rheumatoid Arthritis

Sponsor

Dana Ascherman (Other)

Overall Status

Recruiting

CT.gov ID

NCT02030028

Collaborator

Mallinckrodt (Industry)

Enrollment

Location

Arm

91.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.

ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: ACTHAR gel	N/A

Detailed Description

This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: ACTHAR Gel Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.	Drug: ACTHAR gel Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks. Other Names: Adrenocorticotropic hormone

Arm

Intervention/Treatment

Other: ACTHAR Gel

Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.

Drug: ACTHAR gel

Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.

Other Names:

Adrenocorticotropic hormone

Outcome Measures

Primary Outcome Measures

Changes in Clinical Disease Activity Index [12 weeks]
We propose a 20% improvement after 12 weeks of therapy compared to baseline as a positive response.

Secondary Outcome Measures

Change in the Disease Activity Score [12 weeks]
We expect an improvement in the disease activity score along with an improved C-Reactive protein value.
Changes in acute phase reactants [12 weeks]
We expect the erythrocyte sedimentation rate (ESR) and the C-reactive protein value to improve.
Patient reported changes in fatigue [12 weeks]
We expect patient to report using the FACIT-F scoring tool to report improvement in their level of fatigue.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 year of age and older
RA diagnosis by American College of Rheumatology criteria
Active disease (CDAI > 10)
Have received at least are biologic agent for at least 6 months
May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
No current active infections requiring antibiotics
Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)

Exclusion Criteria:

Less than 18 years of age
Unable or unwilling to give Informed Consent
Have an active infection requiring the use of antibiotics
Women who are pregnant
Uncontrolled hypertension
Abnormal renal function
Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.