Psoriatic ArthritisPhase 4CLIPSNCT03419650
Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)
A Phase 4 study testing ACTHar in people with Psoriatic Arthritis, run by IRIS Research and Development, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- ACTHar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 25 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- A negative test result for the presence of rheumatoid factor by any method, according to the local laboratory reference range.
- Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist.
- 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.
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- 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.
- Plaquenil Azathioprine
- Concomitant treatments:
- Corticosteroids up to 10 mg/day prednisone or prednisone equivalent are allowed for 4 weeks stable dose before the study and can be tapered according to the investigator criteria of clinical response. NSAIDS and COX 2 medications can be used in clinically accepted doses and in stable doses 4 weeks prior to screening. Topical keratolytics such as corticosteroids, tars, anthralin, vitamin D analogs, and retinoids must be discontinued 2 weeks prior to the screening date. Non-medicated emollients including 1% hydrocortisone for palms and soles are allowed. UV light therapy needs to be discontinued 2 weeks prior to screening, and PUVA 4 weeks prior to screening.
- A male participant must agree to use and to have their female partners use a highly effective form of contraception, one day before the first dose of study treatment (as appropriate), during the treatment period, and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: age related amenorrhea for at least one year, and increased follicle-stimulating hormone (FSH) >40 Miu/Ml or who have undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing.
- A woman of childbearing potential is defined as a female capable of becoming pregnant. It is also defined as any female who has experienced menarche and is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without alternative medical cause.
- Women of childbearing potential must agree to at least one method of birth control: a barrier method together or alone with a highly effective method to prevent pregnancy four weeks prior to randomization, throughout the study.
- The definition of highly effective contraception includes:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal,
- Progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable,
- Intrauterine device,
- Intrauterine hormone-releasing system,
- Bilateral tubal occlusion,
- Vasectomized partner, or
- Sexual abstinence. b. Supplementary barrier methods include:
- Male or female condom with or without spermicide, or
- Cap, diaphragm or sponge with spermicide, c. Men must agree to use and have their female partners use a barrier method together with a highly effective contraceptive method as defined above.
Who cannot join
- 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.
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- 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.
- Alcohol abuse unless documented remission for more than 6 months
- Acute psychiatric disorders or conditions that can alter the judgment of the subject.
- Active Hepatitis B, and/or Hepatitis C.
- Within one month prior to Screening, vaccination with live or live-attenuated virus vaccine.
- Allergy to porcine derived substances, participants with congestive heart failure, and with osteoporosis are also excluded from the trial.
- MRI related exclusion criteria In addition to the subjects matching the inclusion/exclusion criteria above, patients meeting any of the below must be excluded from the study.
- Known allergy to gadolinium or any of the excipients contained in the MRI contrast agent
- History of allergy
- Any metal objects e.g. Shrapnel, any surgical clips, pacemakers, pins, plates, screws, metal sutures or wire mesh also including uterine coil.
- Claustrophobia
- Morbid Obesity (BMI > 40kg/m2)
- Cochlear implants Caution is required for patients with tattoos: the patient should inform the MRI technician site staff, who will then be able to assess whether it is sage for the patient to undergo the MRI scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
IRIS Research and Development
Plantation, Florida, 33324
About this study
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.
Read the 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
- 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
- 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]
- Secondary Outcome Measures:
Secondary Imaging Endpoints
- 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]
- Conditions
- Psoriatic Arthritis
- Being tested
- ACTHar
- Keywords
- PsA
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTHarDrug
Also called acthar gel
Acthar™ 80 units twice a week for 4 weeks followed by 40 units twice a week until week 12.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Other | treatment arm for 12 weeks followed by observation period of 12 weeks, and a bone density at week 52. Receives: Drug: ACTHar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Clinical Endpoint
- 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.
Measured: 12 weeks
Primary Imaging Endpoints
- 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]
Measured: baseline to week 24
Secondary outcomes (1)
Secondary Imaging Endpoints
- 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]
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start20 Jul 2018
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- treatment arm will then be observed.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRIS Research and Development, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Guillermo Valenzuela, MD, IRIS Research and Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419650
- Sponsor's protocol ID
- AC0014
- Acronym
- CLIPS
- Status last verified
- Aug 2021
- First submitted
- 14 Nov 2017
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)
- ClinicalTrials.gov ID
- NCT03419650
- Acronym / sponsor ID
- CLIPS / AC0014
- Conditions
- Psoriatic Arthritis
- Keywords
- PsA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- IRIS Research and Development, LLCUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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]
- Secondary Outcome Measures:
Secondary Imaging Endpoints
- 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]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- treatment arm will then be observed.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Other | Drug: ACTHartreatment arm for 12 weeks followed by observation period of 12 weeks, and a bone density at week 52. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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.
- 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:
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTHarAlso: acthar gelActhar™ 80 units twice a week for 4 weeks followed by 40 units twice a week until week 12. | Drug | Treatment arm |
Primary outcome
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.
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]
1 secondary outcome
Secondary Imaging Endpoints
Time frame: baseline to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACTHar in people with Psoriatic Arthritis, run by IRIS Research and Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Clinical Endpoint (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.