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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 May 2015
Main ID:  NCT02434757
Date of registration: 30/04/2015
Prospective Registration: No
Primary sponsor: Ronald J. Rapoport, MD
Public title: Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
Scientific title: Addition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs
Date of first enrolment: February 2014
Target sample size: 10
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02434757
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Arlene Turgeon
Address: 
Telephone: 508-235-6468
Email: arleneturgeon@yahoo.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: H.P. Acthar Gel
Primary Outcome(s)
20%, 50%, 70% Improvement based on American College of Rheumatology Criteria [Time Frame: After 12 weeks]
Percentage of patients with reduction of >1.2 points in DAS-28 score [Time Frame: After 12 weeks]
Secondary Outcome(s)
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]
Secondary ID(s)
ACT1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Questcor Pharmaceuticals, Inc.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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