Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)

NCT03419650 | Completed Phase 4 FDA Drug

• 1 other identifier: AC0014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrate the clinical value of Acthar TM in patients with active Psoriatic Arthritis who lack adequate response to DMARDS, and the quantification of response by clinical, serologic and structural parameters.

Conditions

Psoriatic Arthritis

Keywords

PsA

Outcome Measures

Primary Outcomes (2)

• Primary Clinical Endpoint

  1\. To demonstrate the efficacy of Acthar for the treatment of patients with active psoriatic arthritis and who have not had an adequate response to non-biological DMARDs based on the proportion of subjects achieving a 20% improvement in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, Health Assessment Questionnaire (HAQ), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) as described by American College of Rheumatology (ACR) 20 at week 12.

  12 weeks

• Primary Imaging Endpoints

  1\. The improvement of the total DEMRIQ\*-Volume score of synovial inflammation measured in the Metacarpophalangeal (MCP), proximal interphalangeal (PIP) and the distal interphalangeal (DIP) joints. \[Time Frame: baseline to week 24\]

  baseline to week 24

Secondary Outcomes (1)

• Secondary Imaging Endpoints

  baseline to week 24

Study Arms (1)

Treatment arm

OTHER

treatment arm for 12 weeks followed by observation period of 12 weeks, and a bone density at week 52.

Drug: ACTHar

Interventions

ACTHar DRUG

Acthar™ 80 units twice a week for 4 weeks followed by 40 units twice a week until week 12.

Also known as: acthar gel

Treatment arm

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent before any study-related procedure is undertaken that is not part of the standard subject management
• Subjects are willing to comply with the structure of the study, such as visits, treatment plan, laboratory and imaging studies.
• Clinical evidence of psoriatic arthritis defined by at least 6 months of CASPAR defined criteria (evidence of current psoriasis, a personal history of psoriasis, or a family history of psoriasis. Current psoriasis is defined as psoriatic skin or scalp disease present today as judged by a rheumatologist or dermatologist. A personal history of psoriasis is defined as a history of psoriasis that may be obtained from a patient, family physician, dermatologist, rheumatologist, or other qualified health care provider. A family history of psoriasis is defined as a history of psoriasis in a first- or second-degree relative according to patient report, and the number of tender and swollen joints as later specified. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination.
• c. A negative test result for the presence of rheumatoid factor by any method, according to the local laboratory reference range.
• d. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist.
• e. Radiographic evidence of juxtaarticular new bone formation, appearing as ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot.
• Current psoriasis is assigned a score of 2; all other features are assigned a score of 1.
• The subject must have active arthritis at both screening and baseline, as defined by having both:
• Tender/painful joints on motion (out of 68 joints assessed); and;
• Swollen joints (out of 66 joints assessed). The subject must have active Plaque Psoriasis, which has been diagnosed, or confirmed by a rheumatologist or dermatologist and the ability to use skin biopsy as a diagnostic method.
• Previous use of DMARDS:
• The practices for the administration of DMARD therapy, including laboratory testing, contraceptive requirements, follow-up care and contraindications should be performed according to local standards of care such as the ACR recommendations for monitoring for the duration of the study. Subjects should remain on a stable dose of that traditional DMARD throughout the course of the study.
• Methotrexate: Maximum dose of 15 mg/week. Minimum duration of therapy 3 months and dose stable for 4 weeks prior to first dose of the study. Subjects on methotrexate should be on an adequate and stable dose of folate supplementation.
• Sulfasalazine: Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of study drug.
• Leflunomide: Maximum dose of 20 mg/day. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of study drug.

You may not qualify if:

• Other forms of psoriasis than plaque psoriasis.
• Any person in direct relation to the study site such as employees or family members.
• Breast feeding females, pregnant females or women in childbearing age not using adequate contraception.
• Subjects participating in other concomitant investigational protocols.
• Concurrent forms of severe, progressive disease such as renal, hepatic, hematological, gastrointestinal, pulmonary, neurologic and metabolic.
• Blood cell count below 9g/dl of hemoglobin, wbc count of less than 3000/cubic millimeters, neutropenia of less than 1500/cubic millimeter, platelet count below 100,000/cubic millimeter.
• Creatinine clearance of less than 40ml/min
• Total bilirubin or transaminases 1.5 the normal value.
• Known immunodeficiency
• Subjects with other known autoimmune rheumatic disorder such as (Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD)), or other known inflammatory disorders like gout, Lyme disease, infectious disorders.
• History of Infected prosthesis
• History of lymphoprolipherative disorder
• History of recurrent disseminated herpetic infections.
• Active infections, recent hospitalization for a condition requiring intravenous antibiotics, for three months since discharge.
• Any form of biologic agent or patients who are active on chemotherapy or chemotherapy or any biologic within 6 months of the last treatment dose.

Sponsors & Collaborators

• IRIS Research and Development, LLC: lead
• Mallinckrodt: collaborator

Study Sites (1)

IRIS Research and Development

Plantation, Florida, 33324, United States

Location

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatologist

Model Details: treatment arm will then be observed.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: February 5, 2018
• Study Start: July 20, 2018
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

US (1)