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

NCT ID: NCT01939132

Last Updated: 2013-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-11-30

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.

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; ACTH; Acthar

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Open label H.P. Acthar Gel

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ACTH

Eligibility 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):

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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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Fiechtner, Justus J., M.D., P.C.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Justus J. Fiechtner, MD, PC

Lansing, Michigan, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Tresa Montroy

Role: primary

Amanda Hutchins

Role: backup

Other Identifiers

02131985

Identifier Type: -

Identifier Source: org_study_id