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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Repository corticotropin injection

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Joint pain, Repository corticotropin injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arthritis Treatment Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repository corticotropin injection

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01966718

First Posted

October 14, 2013

Last Updated

July 11, 2016

Sponsor

Arthritis Treatment Center, Maryland

1. Study Identification

Unique Protocol Identification Number

NCT01966718

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Arthritis Treatment Center, Maryland

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Joint pain, Repository corticotropin injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Repository corticotropin injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Repository corticotropin injection

Other Intervention Name(s)

H. P. Acthar Gel

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in the Ritchey-Camp Articular Index

Description

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

Title

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

Description

Time Frame

From baseline to week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)

Description

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

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathan Wei, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arthritis Treatment Center

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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