ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Verified November 2013 by Dartmouth-Hitchcock Medical Center
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Richard C. Chou, Dartmouth-Hitchcock Medical Center
First received: November 8, 2013
Last updated: November 13, 2013
Last verified: November 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
||Adenocorticotrophic Hormone for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Primary Outcome Measures:
- Improvement in disease activity as measured by ACR20 and ACR50. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- adverse events [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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.
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.
Active Comparator: NSAID treatment
Rheumatoid arthritis patients with inadequate response to methotrexate will be treated with scheduled ibuprofen or naproxen for a period of four weeks.
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984268
|Dartmouth-Hitchcock Medical Center
|Lebanon, New Hampshire, United States, 03756 |
|Contact: Richard C. Chou, MD PhD 603-650-8622 firstname.lastname@example.org |
|Principal Investigator: Richard C Chou, MD PhD |
|Dartmouth-Hitchcock Medical Center
|Manchester, New Hampshire, United States, 03104 |
|Contact: John H Yost, MD 603-695-2500 email@example.com |
|Sub-Investigator: John H Yost, MD |
Dartmouth-Hitchcock Medical Center
Questcor Pharmaceuticals, Inc.
||Richard C Chou, MD PhD
||Dartmouth-Hitchcock Medical Center
No publications provided
||Richard C. Chou, Assistant Professor and Physician, Dartmouth-Hitchcock Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 8, 2013
||November 13, 2013
||United States: Institutional Review Board
Keywords provided by Dartmouth-Hitchcock Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014
Connective Tissue Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents