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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: 5 September 2016
Main ID:  NCT01984268
Date of registration: 08/11/2013
Prospective Registration: Yes
Primary sponsor: Dartmouth-Hitchcock Medical Center
Public title: ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Scientific title: Adenocorticotrophic Hormone for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Date of first enrolment: June 2014
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT01984268
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Richard C Chou, MD PhD
Address: 
Telephone: 603-6508622
Email: richard.c.chou@hitchcock.org
Affiliation: 
Name:     Richard C Chou, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Dartmouth-Hitchcock Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female at least 18 years of age at the time of screening

- Subject is diagnosed with RA no less than 6 months prior to the screening

- Subject meets the 2010 ACR/EULAR Classification Criteria for RA (Arthritis Rheum
2010:62;2569-2581) with a score of =6

- Subject is seropositive for RF and/or anti-CCP antibodies as part of the diagnostic
criteria for RA

- Subject has moderately to severely active RA during screening, as defined by a
DAS28-ESR > 3.2

- Subject has moderately to severely active RA defined as the presence of at least 6/68
tender joints and at least 6/66 swollen joints

- Subject has had an inadequate response to the continuous use of methotrexate for at
least 12 weeks prior to study entry with a nonchanging dose for at least 8 weeks
prior to study entry

Exclusion Criteria:

- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the
investigational drug, whichever is longer) of screening

- Treatment with any biological agents within 4 weeks (or 5 half-lives of the agent,
whichever is longer) of screening

- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline

- Evidence of serious uncontrolled concomitant cardiovascular, nervous system,
pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine
(including Cushing's disease or uncontrolled diabetes mellitus) or gastrointestinal
disease (including complicated diverticulitis, ulcerative colitis, or Crohn's
disease.)

- Current liver disease as determined by principal investigator unless related to
primary disease under investigation

- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
or other infections (including but not limited to tuberculosis and atypical
mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal
infections of nail beds)

- Any major episode of infection requiring hospitalization or treatment with IV
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
screening

- Active TB requiring treatment within the previous 3 years. Patients should be
screened for latent TB and, if positive, treated following local practice guidelines
prior to initiating treatment. Patients treated for tuberculosis with no recurrence
in 3 years are permitted.

- Evidence of active malignant disease, malignancies diagnosed within the previous 10
years (including hematological malignancies and solid tumors, except basal and
squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has
been excised and cured), or breast cancer diagnosed within the previous 20 years
unless related to primary disease under investigation

- Pregnant women or nursing (breast feeding) mothers

- Patients with reproductive potential not willing to use an effective method of
contraception.

- History of alcohol, drug or chemical abuse within 1 year prior to screening.

- Neuropathies or other conditions that might interfere with pain evaluation unless
related to primary disease under investigation.

- Body weight of > 150 kg

- Serum creatinine > 1.6 mg/dL (141 ┬Ámol/L) in female subjects and > 1.9 mg/dL (168
┬Ámol/L) in male subjects. Subjects with serum creatinine values exceeding limits may
be eligible for the study if their estimated glomerular filtration rates (GFR) are
>30

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper
limit of normal (ULN)

- Total Bilirubin > ULN

- Platelet count < 100 x 109/L (100,000/mm3)

- Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)

- White Blood Cells < 3.0 x 109/L (3000/mm3)

- Absolute Neutrophil Count < 2.0 x 109/L (2000/mm3)

- Absolute Lymphocyte Count < 0.5 x 109/L (500/mm3)

- Positive Hepatitis BsAg or Hepatitis C antibody

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization

- A diagnosis of any of the followings: scleroderma, osteoporosis, infection throughout
the body, ocular herpes simplex, history of or a current stomach ulcer, uncontrolled
hypertension (systolic blood pressure greater than 160), or allergy to pig-derived
proteins

- Subject does not tolerate methotrexate and/or NSAID due to side effects or toxicities



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: ACTHAR
Primary Outcome(s)
Improvement in disease activity as measured by ACR20 and ACR50. [Time Frame: 36 weeks]
Secondary Outcome(s)
adverse events [Time Frame: 36 weeks]
Secondary ID(s)
D13146
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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