Psoriatic ArthritisPhase 4NCT01939132
Protocol for H.P. Acthar Gel in Moderately to Severely Active Psoriatic Arthritis
A Phase 4 study testing Open label H.P. Acthar Gel in people with Psoriatic Arthritis, run by Fiechtner, Justus J., M.D., P.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Open label H.P. Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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):
- -
Who cannot join
- 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
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- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Justus J. Fiechtner, MD, PC
Lansing, Michigan, 48910
Tresa Montroy, 517-272-9727 ext. 24, rheumresearch66@gmail.com
Amanda Hutchins, 517-272-9727 ext. 24, ahutchins0213@yahoo.com
About this study
Official title: Title of Study: A Single-Site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection) an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Psoriatic Arthritis (PsA)
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.
Read the 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
- Being tested
- Open label H.P. Acthar Gel
- Keywords
- Psoriatic Arthritis, ACTH, Acthar
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open label H.P. Acthar GelDrug
Also called ACTH
Open-label H.P. Acthar Gel 80 units given subcutaneously twice weekly for 12 weeks with 12 week extension.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Open label H.P. Acthar Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (1)
Adverse Events
Adverse events and vital signs will be measured and monitored for 24 weeks.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionNov 2014 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fiechtner, Justus J., M.D., P.C.
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939132
- Sponsor's protocol ID
- 02131985
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title of Study: A Single-Site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection) an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Psoriatic Arthritis (PsA)
- ClinicalTrials.gov ID
- NCT01939132
- Acronym / sponsor ID
- 02131985
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, ACTH, Acthar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fiechtner, Justus J., M.D., P.C.
- Collaborators
- Mallinckrodt
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 11 Sep 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.P. Acthar Gel SQ injection | Experimental | Drug: Open label H.P. Acthar GelOpen-label H.P. Acthar Gel 80 units subcutaneously twice weekly for 12 weeks with a 12 week extension. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| Open label H.P. Acthar GelAlso: ACTHOpen-label H.P. Acthar Gel 80 units given subcutaneously twice weekly for 12 weeks with 12 week extension. | Drug | H.P. Acthar Gel SQ injection |
Primary outcome
ACR20 (American College of Rheumatology 20)
Time frame: Week 12
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
1 secondary outcome
Adverse Events
Time frame: 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
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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.
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 Open label H.P. Acthar Gel in people with Psoriatic Arthritis, run by Fiechtner, Justus J., M.D., P.C. 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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR20 (American College of Rheumatology 20) (time frame: Week 12). 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 11 Sep 2013.