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

NCT01966718 | Completed Phase 4 Results

• 1 other identifier: ATC 005
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Joint pain; Repository corticotropin injection

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From baseline to week 16

Secondary Outcomes (2)

• Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)

  From baseline to week 16

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

  From baseline to week 16

Study Arms (1)

Repository corticotropin injection

EXPERIMENTAL

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

Drug: Repository corticotropin injection

Interventions

Repository corticotropin injection DRUG

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

Also known as: H. P. Acthar Gel

Repository corticotropin injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior treatment with Acthar Gel
• History of intolerance or allergy to glucocorticoids
• Unstable diabetes
• Active infection

Sponsors & Collaborators

• Arthritis Treatment Center, Maryland: lead

Study Sites (1)

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthralgia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size (8 patients); Open label, Sampling bias cannot be excluded;Single group study; no standardization of concomitant therapy

Results Point of Contact

• Title: Dr. Nathan Wei
• Organization: Arthritis Treatment Center

nwei@arthritistreatmentcenter.com

301-694-5800

Study Officials

• Nathan Wei, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nathan Wei, MD, FACP, FACR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 22, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-07

Locations

US (1)