Lupus Erythematosus Systemic ExacerbationPhase 4ACTHNCT01769937
Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 4 study testing H.P. Acthar Gel in people with Lupus Erythematosus Systemic Exacerbation, run by Fiechtner, Justus J., M.D., P.C. at 1 site in United States.
Trial summary
Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need. The aim of this Investigator Initiated, single center, open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ) injection of H.P. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus Systemic Exacerbation
- What is being tested?
- 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
- Oct 2012to Apr 2013
- 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
- Subjects must meet all of the following criteria:
- 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 (eg. HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, including a history of ANA positivity
- Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for > 8 weeks prior to screening.
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- Currently receiving at least one of the following:
- A stable dose of oral prednisone (or equivalent) < 20mg/day from at least 4weeks (28 days) prior to signing of the informed consent
- Any of the following medications administered at a stable dose for a minimum of 8 weeks (56 days) prior to signing of the informed consent form
- Azathioprine ii) Antimalarials (eg. Chloroquine, hydroxychloroquine, quinacrine) iii) Mycophenolate mofetil/mycophenolic acid iv) Weekly administration of oral or SQ Methotrexate
- At screening and randomization (Day 0) must meet SLE Flare criteria
- Females of childbearing potential must use an effective method of birth control and avoid pregnancy from screening through 90 days after the final dose of Acthar 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.
- -
Who cannot join
- Any of the following would exclude the subject from participation in the study:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or confound interpretation of subject safety or study results
- Concurrent enrollment in any other clinical study with an investigational product with 4 weeks (28 days) prior to Day 0 or within 5 half-lives of the investigational product used in that clinical study, whichever is longer
- Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals
- Any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) anytime from 4 weeks (28 days) prior to signing of the informed consent
- A known history of allergy or reaction to any component of the investigational product
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- Any live or attenuated vaccine within 4 weeks (28 days) prior to signing the informed consent form (administration of killed vaccines is acceptable)
- Diagnosis of scleroderma, osteoporosis, fungal infections, ocular herpes simplex, surgery within the past 4 weeks (28 days) or planned surgery within the next 4 weeks (28 days)
- History of or presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency or adrenocortical hyperfunction or sensitivity to proteins of porcine origin
- Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the subject to infection
- History of any type of malignancy <5 years before randomization into the study (apart from basal cell carcinoma)
- Receipt of more than one prescribed NSAID at an anti-inflammatory dose with 4 weeks (28 days) prior to Day 0
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 Systemic Lupus Erythematosus (SLE)
Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need. The aim of this Investigator Initiated, single center, open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ) injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for non-responders after day 10 dose. The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
Read the detailed description
This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with H.P. Acthar Gel.
The primary objective is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
The secondary objective is to evaluate any changes to the subjects BILAG scores and markers of inflammation, e.g. ESR and/or CRP.
The Exploratory objective will determine the feasibility of a long-term double-blind study using H.P. Acthar Gel versus other usual treatments for lupus.
- Being tested
- H.P. Acthar Gel
- Keywords
- Lupus, SLE, ACTH, Acthar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. Acthar GelDrug
Also called ACTH
Open-label H.P. Acthar Gel given subcutaneous injection once daily for 10 days with potential for additional 5 days of dosing
| Study group | Role | What they receive |
|---|---|---|
| H.P. Acthar Gel SQ injection | Experimental | Patients will administer single dose (80 units) of Acthar subcutaneously every day for 10 days (with a possible 5 day dosing rescue). Receives: Drug: H.P. Acthar Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLEDAI-2K score
The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
Measured: 14 days
Secondary outcomes (1)
BILAG-2004
To evaluate any changes to the subjects BILAG scores and markers of inflammation, e.g. ESR and/or CRP.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus Systemic ExacerbationStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fiechtner, Justus J., M.D., P.C.
- Responsible party
- Sponsor-investigator, Fiechtner, Justus J., M.D., P.C., Fiechtner, Justus J., M.D., P.C.
- Investigators
- Justus J Fiechtner, MD, MPH, Principal investigator, Justus J. Fiechtner, MD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769937
- Sponsor's protocol ID
- 11191966
- Acronym
- ACTH
- Status last verified
- Jul 2013
- First submitted
- 15 Jan 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT01769937
- Acronym / sponsor ID
- ACTH / 11191966
- Keywords
- Lupus, SLE, ACTH, Acthar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fiechtner, Justus J., M.D., P.C.
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Jan 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.
Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need. The aim of this Investigator Initiated, single center, open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ) injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for non-responders after day 10 dose. The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
Detailed description
This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with H.P. Acthar Gel.
The primary objective is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
The secondary objective is to evaluate any changes to the subjects BILAG scores and markers of inflammation, e.g. ESR and/or CRP.
The Exploratory objective will determine the feasibility of a long-term double-blind study using H.P. Acthar Gel versus other usual treatments for lupus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.P. Acthar Gel SQ injection | Experimental | Drug: H.P. Acthar GelPatients will administer single dose (80 units) of Acthar subcutaneously every day for 10 days (with a possible 5 day dosing rescue). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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 (eg. HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, including a history of ANA positivity
- Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for > 8 weeks prior to screening.
Key exclusion criteria (13 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or confound interpretation of subject safety or study results
- Concurrent enrollment in any other clinical study with an investigational product with 4 weeks (28 days) prior to Day 0 or within 5 half-lives of the investigational product used in that clinical study, whichever is longer
- Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals
- Any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) anytime from 4 weeks (28 days) prior to signing of the informed consent
- A known history of allergy or reaction to any component of the investigational product
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 |
|---|---|---|
| H.P. Acthar GelAlso: ACTHOpen-label H.P. Acthar Gel given subcutaneous injection once daily for 10 days with potential for additional 5 days of dosing | Drug | H.P. Acthar Gel SQ injection |
Primary outcome
SLEDAI-2K score
Time frame: 14 days
The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
1 secondary outcome
BILAG-2004
Time frame: 14 days
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 23 Jul 2013.
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.
Justus J Fiechtner, MD, MPH principal investigator
Justus J. Fiechtner, MD, PC
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 H.P. Acthar Gel in people with Lupus Erythematosus Systemic Exacerbation, 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 13 inclusion and 13 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 23 Jul 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?
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?
SLEDAI-2K score (time frame: 14 days). 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 23 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.