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ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

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ClinicalTrials.gov Identifier: NCT01984268
Recruitment Status : Unknown
Verified August 2016 by Richard C. Chou, Dartmouth-Hitchcock Medical Center.
Recruitment status was:  Recruiting
First Posted : November 14, 2013
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Richard C. Chou, Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ACTHAR Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adenocorticotrophic Hormone for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Study Start Date : June 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: ACTHAR
Other Name: Corticotropin

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.
Drug: ACTHAR
Other Name: Corticotropin




Primary Outcome Measures :
  1. Improvement in disease activity as measured by ACR20 and ACR50. [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 36 weeks ]

Other Outcome Measures:
  1. Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: 36 weeks ]
  2. Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) [ Time Frame: 36 weeks ]
  3. Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) [ Time Frame: 36 weeks ]
  4. Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) [ Time Frame: 36 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984268


Contacts
Contact: Richard C Chou, MD PhD 603-6508622 richard.c.chou@hitchcock.org
Contact: Lisa M Davis, B.S.

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Richard C. Chou, MD PhD    603-650-8622    richard.c.chou@hitchcock.org   
Principal Investigator: Richard C Chou, MD PhD         
Dartmouth-Hitchcock Medical Center Recruiting
Manchester, New Hampshire, United States, 03104
Contact: John H Yost, MD    603-695-2500    john.h.yost@hitchcock.org   
Sub-Investigator: John H Yost, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Mallinckrodt
Investigators
Principal Investigator: Richard C Chou, MD PhD Dartmouth-Hitchcock Medical Center

Responsible Party: Richard C. Chou, Assistant Professor and Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01984268     History of Changes
Other Study ID Numbers: D13146
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Richard C. Chou, Dartmouth-Hitchcock Medical Center:
Rheumatoid arthritis
ACTHAR
Methotrexate
Inadequate response

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adrenocorticotropic Hormone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists