- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01984268
ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
December 21, 2020 updated by: Dartmouth-Hitchcock Medical Center
Adenocorticotrophic Hormone for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Adenocorticotrophic Hormone provides safe and effective treatment to induce disease remission in rheumatoid arthritis patients with active disease due to an inadequate response to methotrexate.
Study Overview
Detailed Description
The standard treatment for rheumatoid arthritis is using disease-modifying anti-rheumatic drugs such as methotrexate to control joint pain and swelling.
Often times rheumatoid arthritis patients experience inadequate response to methotrexate with acute or persistent joint pain and swelling.
In these patients, alternative or additional immunosuppressive therapy is needed to induce disease remission.
In the present clinical trial, ACTHAR is being studied to induce disease remission on rheumatoid arthritis patients who have inadequate response to methotrexate therapy.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 µmol/L) in female subjects and > 1.9 mg/dL (168 µmol/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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Four week ACTHAR treatment
Rheumatoid arthritis subjects with inadequate response to methotrexate will be randomized to receive twice a week dosing of ACTHAR for a period of four weeks.
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Other Names:
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Experimental: Twelve week ACTHAR treatment
Rheumatoid arthritis subjects with inadequate response to methotrexate will be randomized to receive twice a week dosing of ACTHAR for a period of twelve weeks.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in Disease Activity as Measured by ACR20 and ACR50.
Time Frame: 36 weeks
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36 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 36 weeks
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36 weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: 36 weeks
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36 weeks
|
Change From Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS)
Time Frame: 36 weeks
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36 weeks
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Change From Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS)
Time Frame: 36 weeks
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36 weeks
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Change From Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: 36 weeks
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36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard C Chou, MD PhD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 23, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
November 8, 2013
First Submitted That Met QC Criteria
November 13, 2013
First Posted (Estimate)
November 14, 2013
Study Record Updates
Last Update Posted (Actual)
January 15, 2021
Last Update Submitted That Met QC Criteria
December 21, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D13146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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