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

NCT01939132 | Unknown Phase 4

• 1 other identifier: 02131985
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; ACTH; Acthar

Outcome Measures

Primary Outcomes (1)

• ACR20 (American College of Rheumatology 20)

  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

  Week 12

Secondary Outcomes (1)

• Adverse Events

  24 Weeks

Other Outcomes (3)

• Clinical Disease Activity Index (CDAI)

  12 weeks

• Disease Activity Index 28 (DAS28)

  12 weeks

• Dactylitis (Digit Inflammation)

  12 weeks

Study Arms (1)

H.P. Acthar Gel SQ injection

EXPERIMENTAL

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

Interventions

Open label H.P. Acthar Gel DRUG

Open-label H.P. Acthar Gel 80 units given subcutaneously twice weekly for 12 weeks with 12 week extension.

Also known as: ACTH

H.P. Acthar Gel SQ injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 18-75 years at the time of screening
• 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.
• Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months.
• Subject must have \> 6 tender and \>6 swollen joint count at screening.
• Subject must have \> 30 minutes of morning joint stiffness.
• 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.
• 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.
• 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.
• 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
• 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):

You may not qualify if:

• Subject has a planned surgical intervention between baseline and the week 24 evaluation.
• 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)
• Subject has a diagnosis of scleroderma, osteoporosis, fungal infections or ocular herpes simplex
• History of any type of malignancy \<5 years before enrollment into the study (apart from basal cell carcinoma)
• Any live or attenuated vaccine within 4 weeks prior to signing the informed consent form (administration of killed vaccines is acceptable)
• Subject has active tuberculosis
• Any know history of allergy or reaction to any component of H.P. Acthar Gel
• Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection.
• Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals
• Concurrent enrollment in any other clinical study with an investigational product within 4 weeks prior to enrollment into the study.
• 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

Sponsors & Collaborators

• Fiechtner, Justus J., M.D., P.C.: lead
• Mallinckrodt: collaborator

Study Sites (1)

Justus J. Fiechtner, MD, PC

Lansing, Michigan, 48910, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 11, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

US (1)