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Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02434757
Recruitment Status : Unknown
Verified September 2014 by Ronald J. Rapoport, MD, Phase III Clinical Research.
Recruitment status was:  Recruiting
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Ronald J. Rapoport, MD, Phase III Clinical Research

Tracking Information
First Submitted Date  ICMJE April 30, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date May 5, 2015
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Percentage of patients with reduction of >1.2 points in DAS-28 score [ Time Frame: After 12 weeks ]
  • 20%, 50%, 70% Improvement based on American College of Rheumatology Criteria [ Time Frame: After 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Improvement (decrease) in Vectra Disease Activity score [ Time Frame: After 12 weeks ]
  • Improvement (decrease) in Health Assessment Questionnaire [ Time Frame: After 12 weeks ]
  • Improvement in Functional Assessment of Chronic Illness Therapy Health Related Quality of Life Score [ Time Frame: After 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
Official Title  ICMJE Addition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs
Brief Summary This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in adequate response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus C-Reactive Protein (CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20 week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers and private practice settings in the US. A total of 20 eligible patients will be enrolled and other standard RA therapeutic agents, such as Methotrexate, DMARDs, non-steroidal anti-inflammatory drugs (NSAIDs), pain medications and others will not be discontinued. The primary endpoint will be the percentage of patients with reduction of ≥1.2 points of the Disease Activity Score in 28 joints (DAS-28) score.
Detailed Description >
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: H.P. Acthar Gel
Acthar 40 U given SC daily for 7 days. Depending on the response and the Investigator,Acthar 40 U will continue Acthar 40 U 2x per week or increase to Acthar 80 U daily for 7 days followed by 2x per week
Other Names:
  • Acthar
  • Repository Corticotropin Injection
  • ACTH Gel
Study Arms  ICMJE Experimental: Acthar 40 U
Acthar 40 U (0.5mL)
Intervention: Drug: H.P. Acthar Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 18 years of age at the time of participation
  • Have a confirmed diagnosis of RA based on the 2010 ACR/EULAR criteria
  • Currently on aggressive treatment with an inadequate response or AE to stable dose of DMARDs and biologic agents for 3 months prior to screening, and stable doses of NSAIDs, prednisone or equivalent dose of corticosteroid (dose ≥7.5 mg/d), and analgesics for 28 days prior to screening. Have active RA, defined as ≥6 swollen joints, ≥6 tender joints, plus CRP levels an /or an ESR ≥1.2 the upper limit of normal
  • RA for art least 24 months and receiving maximum tolerated doses of at lease 3 biologic agents (at least 1 of which is anti-TNF-a) for 3 months
  • Tuberculosis has not occurred within the recent past, as proven by a conventional x-ray, negative tuberculosis shin test (PPD), or quantiferon gold

Exclusion Criteria:

  • Presence of any condition which could confound interpretation of the data, such as inflammatory arthritis (eg. psoriatic arthritis, gout or pseudogout)
  • Presence of systemic fungal infections, recent surgery (within prior 3 months), or active ulcer disease (within the past 5 years)
  • Current symptoms of severe, progressive, or uncontrolled renal, hepatic ,hematologic, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
  • Have had in last three months or planning to receive live or live attenuated vaccines
  • Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in the study such as uncontrolled diabetes or hypertension
  • History of or presence of active or latent tuberculosis (TB) based on QuantiFERON-TB gold test. Patients will be allowed in the study after receiving adequate treatment for TB
  • Sensitivity to proteins of porcine origin
  • History of cancer within the last 5 years, excluding basal cell carcinoma
  • Glomerular filtration rate <30 mL/min -
  • Uncontrolled diabetes mellitus
  • Pregnant of lactating female patients. Each site to administer a pregnancy test to any female of childbearing potential before prescribing Acthar Gel. Only females with negative pregnancy test results are eligible. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the period of the study.
  • The following physical and laboratory test findings
  • Patients with positive hepatitis B surface antigen
  • Patients with positive hepatitis C antibody, who are also positive by recombinant immunoblot assay (RIBA) or by polymerase chain reaction (PCR)
  • Hemoglobin level <8.5. g/dL
  • White blood cell count <3000/mm (3 x 10/L)
  • Serum Creatinine level >2 times upper limit of normal
  • Serum alanine aminotransferase (ALT) or asparate amino- transferase (AST) >2 times upper limit of normal
  • Any other laboratory test results that, in the opinion of the investigator might placed the patient at unacceptable risk for participation in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434757
Other Study ID Numbers  ICMJE ACT1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald J. Rapoport, MD, Phase III Clinical Research
Study Sponsor  ICMJE Ronald J. Rapoport, MD
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE Not Provided
PRS Account Phase III Clinical Research
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP