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

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ClinicalTrials.gov Identifier: NCT01966718
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Nathan Wei, MD, FACP, FACR:, Arthritis Treatment Center, Maryland

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Repository corticotropin injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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
Other Name: H. P. Acthar Gel




Primary Outcome Measures :
  1. Change From Baseline in the Ritchey-Camp Articular Index [ Time Frame: From baseline to week 16 ]
    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.

  2. Change From Baseline in the 20-item Health Assessment Questionnaire Score [ Time Frame: From baseline to week 16 ]
    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 :
  1. Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) [ Time Frame: From baseline to week 16 ]
    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

  2. Change From Baseline in the C-Reactive Protein (CRP) Level [ Time Frame: From baseline to week 16 ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966718


Locations
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United States, Maryland
Arthritis Treatment Center
Frederick, Maryland, United States, 21702
Sponsors and Collaborators
Arthritis Treatment Center, Maryland
Investigators
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Principal Investigator: Nathan Wei, MD Nathan Wei, MD dba Arthritis Treatment Center, Frederick, MD 21702 USA

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Responsible Party: Nathan Wei, MD, FACP, FACR:, Nathan Wei, MD, FACP, FACR, Arthritis Treatment Center, Maryland
ClinicalTrials.gov Identifier: NCT01966718     History of Changes
Other Study ID Numbers: ATC 005
First Posted: October 22, 2013    Key Record Dates
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016

Keywords provided by Nathan Wei, MD, FACP, FACR:, Arthritis Treatment Center, Maryland:
Rheumatoid arthritis
Joint pain
Repository corticotropin injection

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs