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

NCT01984268 | Terminated Phase 2 Results DMC

• 1 other identifier: D13146
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; ACTHAR; Methotrexate; Inadequate response

Outcome Measures

Primary Outcomes (1)

• Improvement in Disease Activity as Measured by ACR20 and ACR50.

  36 weeks

Secondary Outcomes (1)

• Adverse Events

  36 weeks

Other Outcomes (4)

• Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)

  36 weeks

• Change From Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS)

  36 weeks

• Change From Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS)

  36 weeks

Study Arms (2)

Four week ACTHAR treatment

EXPERIMENTAL

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

Twelve week ACTHAR treatment

EXPERIMENTAL

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

Interventions

ACTHAR DRUG

Also known as: Corticotropin

Four week ACTHAR treatment; Twelve week ACTHAR treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Mallinckrodt: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Director, Office of Research Operations
• Organization: Dartmouth-Hitchcock Medical Center

Barbara.A.Moskalenko@hitchcock.org

(603) 650-6340

Study Officials

• Richard C Chou, MD PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: June 23, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 15, 2021
• Results First Posted: January 15, 2021

Record last verified: 2020-12

Locations

US (1)