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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: 12 December 2020
Main ID:  NCT02030028
Date of registration: 06/01/2014
Prospective Registration: Yes
Primary sponsor: Dana Ascherman
Public title: ACTH Gel Therapy in Rheumatoid Arthritis
Scientific title: Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
Date of first enrolment: November 2014
Target sample size: 20
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02030028
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Laurie Hope, RN
Address: 
Telephone: 412-647-2638
Email: hopelk@upmc.edu
Affiliation: 
Name:     Laurie Hope, RN
Address: 
Telephone: 412-647-2638
Email: hopelk@upmc.edu
Affiliation: 
Name:     Larry W Moreland, MD
Address: 
Telephone:
Email:
Affiliation:  University of Pittsburgh
Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 year of age and older

- RA diagnosis by American College of Rheumatology criteria

- Active disease (CDAI > 10)

- Have received at least are biologic agent for at least 6 months

- May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of
prednisone equivalent

- No current active infections requiring antibiotics

- Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA
therapies for at least 4 weeks prior to baseline visit)

Exclusion Criteria:

- Less than 18 years of age

- Unable or unwilling to give Informed Consent

- Have an active infection requiring the use of antibiotics

- Women who are pregnant

- Uncontrolled hypertension

- Abnormal renal function

- Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and
aspartate aminotransferase (AST) that is greater than 5 times normal.



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: ACTHAR gel
Primary Outcome(s)
Changes in Clinical Disease Activity Index [Time Frame: 12 weeks]
Secondary Outcome(s)
Change in the Disease Activity Score [Time Frame: 12 weeks]
Changes in acute phase reactants [Time Frame: 12 weeks]
Patient reported changes in fatigue [Time Frame: 12 weeks]
Secondary ID(s)
STUDY19050342
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Mallinckrodt
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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