ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02434757
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: H.P. Acthar Gel Not Applicable

Detailed Description:
>

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs
Study Start Date : February 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acthar 40 U
Acthar 40 U (0.5mL)
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




Primary Outcome Measures :
  1. Percentage of patients with reduction of >1.2 points in DAS-28 score [ Time Frame: After 12 weeks ]
  2. 20%, 50%, 70% Improvement based on American College of Rheumatology Criteria [ Time Frame: After 12 weeks ]

Secondary Outcome Measures :
  1. Improvement (decrease) in Vectra Disease Activity score [ Time Frame: After 12 weeks ]
  2. Improvement (decrease) in Health Assessment Questionnaire [ Time Frame: After 12 weeks ]
  3. Improvement in Functional Assessment of Chronic Illness Therapy Health Related Quality of Life Score [ Time Frame: After 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02434757


Locations
United States, Massachusetts
Phase III Clinical Research Recruiting
Fall River, Massachusetts, United States, 02720
Contact: Arlene Turgeon    508-235-6468    arleneturgeon@yahoo.com   
Principal Investigator: Ronald J. Rapoport, MD         
Sponsors and Collaborators
Ronald J. Rapoport, MD
Mallinckrodt

Responsible Party: Ronald J. Rapoport, MD, Ronald Jay Rapoport, MD, Phase III Clinical Research
ClinicalTrials.gov Identifier: NCT02434757     History of Changes
Other Study ID Numbers: ACT1
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: September 2014

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