Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Protocol for H.P. Acthar Gel in Moderately to Severely Active Psoriatic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Fiechtner, Justus J., M.D., P.C.
Sponsor:
Collaborator:
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Fiechtner, Justus J., M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01939132
First received: September 3, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints, tendon sheaths, entheses, and the axial skeleton as well as skin and nails. This is an open-label trial with H.P. Acthar Gel (80 units/1mL) Subcutaneous injection administered twice weekly. To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks, including American College of Rheumatology 20,Clinical Disease Activity Index, Disease Activity Index 28, Dactylitis and adverse events.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Open label H.P. Acthar Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Title of Study: A Single-Site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection) an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Psoriatic Arthritis (PsA)

Resource links provided by NLM:


Further study details as provided by Fiechtner, Justus J., M.D., P.C.:

Primary Outcome Measures:
  • ACR20 (American College of Rheumatology 20) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    To evaluate the efficacy of H.P. Acthar Gel given subcutaneously twice weekly on the signs and symptoms of psoriatic arthritis after 12 weeks of administration.

    ACR20 (American College of Rheumatology 20) at week 12



Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Adverse events and vital signs will be measured and monitored for 24 weeks.


Other Outcome Measures:
  • Clinical Disease Activity Index (CDAI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Disease Activity Index 28 (DAS28) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Dactylitis (Digit Inflammation) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure inflammation in fingers and toes


Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H.P. Acthar Gel SQ injection
Open-label H.P. Acthar Gel 80 units subcutaneously twice weekly for 12 weeks with a 12 week extension.
Drug: Open label H.P. Acthar Gel
Open-label H.P. Acthar Gel 80 units given subcutaneously twice weekly for 12 weeks with 12 week extension.
Other Name: ACTH

Detailed Description:

The subjects in this study will be adult men and women ages 18-75 years of age at the time of screening with chronic, moderately-to-severely active PsA and meeting ACR criteria.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator, must have adequate reading and writing abilities (in their native language) such that the subject can comprehend and complete the informed consent, and all protocol-related assessments.
  2. Age 18-75 years at the time of screening
  3. Written informed consent and any locally required authorization (e.g. HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  4. Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months.
  5. Subject must have > 6 tender and >6 swollen joint count at screening.
  6. Subject must have > 30 minutes of morning joint stiffness.
  7. For subjects receiving non-steroidal anti-inflammatory drugs (NSAIDs) (including PRN use): the subject must be on stable dose for >4 weeks prior to initiation of H.P. Acthar Gel.
  8. For subjects receiving any Disease-Modifying Anti-Rheumatic Drug (DMARD) or Biologic agent: subject has received treatment for >8 weeks, with a stable does for > 4 weeks prior to initiation of H.P. Acthar Gel.
  9. For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10mg of prednisone per day) for >2 weeks prior to initiation of H.P. Acthar Gel.
  10. Subject has a negative test for tuberculosis within 6 months before initiating H.P. Acthar Gel defined as either:

    • Negative purified protein derivative (PPD)
    • Negative Quantiferon test, or
    • Negative chest x-ray
  11. Females of childbearing potential must use an effective method of birth control and avoid pregnancy from screening through 60 days after final dose of H.P. Acthar Gel unless surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has a sterile male partner, is >1 year postmenopausal or practices abstinence (not have sexual intercourse):

    -

Exclusion Criteria:

  1. Subject has a planned surgical intervention between baseline and the week 24 evaluation.
  2. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (eg, renal failure, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency or adrenocortical hyperfunction, peptic ulcer or sensitivity to proteins of porcine origin)
  3. Subject has a diagnosis of scleroderma, osteoporosis, fungal infections or ocular herpes simplex
  4. History of any type of malignancy <5 years before enrollment into the study (apart from basal cell carcinoma)
  5. Any live or attenuated vaccine within 4 weeks prior to signing the informed consent form (administration of killed vaccines is acceptable)
  6. Subject has active tuberculosis
  7. Any know history of allergy or reaction to any component of H.P. Acthar Gel
  8. Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection.
  9. Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals
  10. Concurrent enrollment in any other clinical study with an investigational product within 4 weeks prior to enrollment into the study.
  11. Lactating or pregnant females or females who intend to become pregnant anytime from initiation of screening through 60 days post last dose of H.P. Acthar Gel

    -

  Contacts and Locations
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: NCT01939132

Locations
United States, Michigan
Justus J. Fiechtner, MD, PC Recruiting
Lansing, Michigan, United States, 48910
Contact: Tresa Montroy    517-272-9727 ext 24    rheumresearch66@gmail.com   
Contact: Amanda Hutchins    517-272-9727 ext 24    ahutchins0213@yahoo.com   
Principal Investigator: Justus J Fiechtner, MD, MPH         
Sponsors and Collaborators
Fiechtner, Justus J., M.D., P.C.
Questcor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Fiechtner, Justus J., M.D., P.C.
ClinicalTrials.gov Identifier: NCT01939132     History of Changes
Other Study ID Numbers: 02131985
Study First Received: September 3, 2013
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Fiechtner, Justus J., M.D., P.C.:
Psoriatic Arthritis
ACTH
Acthar

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014