Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)
Overview
- Phase
- Phase 4
- Intervention
- ACTHar
- Conditions
- Psoriatic Arthritis
- Sponsor
- IRIS Research and Development, LLC
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Primary Imaging Endpoints
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
The study is an investigator initiated study (IIS) single arm treatment, single center where patients will receive active treatment with ActharTM 80 units twice weekly for 4 weeks followed by 40 units twice weekly until week 12. 2-End points: 1.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. \[Time Frame: 12 weeks\] 2.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. \[Time Frame: baseline to week 24\] \[Time Frame: baseline to week 24\] 2. Secondary Outcome Measures: Secondary Imaging Endpoints 1. The improvement in PSAMRIS\* Synovitis score in the Metacarpophalangeal (MCP), proximal interphalangeal (PIP) and the distal interphalangeal (DIP) joints. \[Time Frame: baseline to week 24\] \[Time Frame: baseline to week 24\]
Investigators
Guillermo Valenzuela, MD
Rheumatologist
IRIS Research and Development, LLC
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Treatment arm
treatment arm for 12 weeks followed by observation period of 12 weeks, and a bone density at week 52.
Intervention: ACTHar
Outcomes
Primary Outcomes
Primary Imaging Endpoints
Time Frame: baseline to week 24
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. \[Time Frame: baseline to week 24\]
Primary Clinical Endpoint
Time Frame: 12 weeks
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.
Secondary Outcomes
- Secondary Imaging Endpoints(baseline to week 24)