SarcoidosisPhase 4ACPSNCT02188017
Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)
A Phase 4 study testing Acthar gel in people with Sarcoidosis and Pulmonary Sarcoidosis, run by University of Cincinnati at 1 site in United States.
Trial summary
An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoidosis, Pulmonary Sarcoidosis
- What is being tested?
- Acthar gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23
- Patient on >5 mg prednisone for pulmonary indications
- FVC <85% predicted
- Prednisone dose not reduced in prior 3 months
- Deterioration of pulmonary disease over the past year
- Decrease in FVC >5%
- Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).
Who cannot join
- adrenal insufficiency (Addison's disease)
- Scleroderma
- a fungal infection
- herpes infection of the eyes
- osteoporosis
- a stomach ulcer
Show all 17Show fewer
- congestive heart failure
- high blood pressure
- recent surgery
- if you are allergic to pork proteins
- Do not receive a smallpox vaccine or any "live" vaccine while you are using corticotropin.
- Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab) in prior six months
- Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
- Patients requiring therapy for pulmonary hypertension
- Females of childbearing potential who are known to be pregnant and/or lactating or who have a positive urine pregnancy test on screening.
- Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days)
- Any other condition that the investigator feels would pose a significant hazard to the patient if Acthar Gel therapy is initiated.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Felicia Thompson, 513-584-6252, THOMPSFA@ucmail.uc.edu
Robert P Baughman, MD
About this study
Official title: ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.
Read the detailed description
This is a multi-center double-blind trial to determine dose and effect size. A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States.
After initial evaluation, including pulmonary function, CT and PET scanning, patients will be randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80 units of Acthar gel twice a week for an additional 22 weeks.
At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.
- Conditions
- Sarcoidosis, Pulmonary Sarcoidosis
- Being tested
- Acthar gel
- Keywords
- prednisone, methotrexate, sarcoidosis, azathioprine
- Medical subject headings
- Sarcoidosis, Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar gelDrug
Also called ACTH, Cortysin
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
| Study group | Role | What they receive |
|---|---|---|
| 80 units | Active comparator | 80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading Receives: Drug: Acthar gel |
| 40 units | Active comparator | 40 units of ACTHAR gel will be given twice a week for 22 weeks after loading Receives: Drug: Acthar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid toxicity
Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire
Measured: 24 weeks
Secondary outcomes (4)
Forced Vital Capacity (FVC)
Change in FVC over course of study
Measured: 24 weeks
Chest x-ray
Change in chest x-ray
Measured: 24 weeks
PET scan
Change in lung uptake of PET scan during course of study
Measured: 24 weeks
Sarcoidosis Health Questionnaire
Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire
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 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
- Investigators
- Robert P Baughman, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188017
- Sponsor's protocol ID
- ACPS
- Acronym
- ACPS
- Status last verified
- Dec 2015
- First submitted
- 24 Apr 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baughman RP, Sweiss N, Keijsers R, Birring SS, Shipley R, Saketkoo LA, Lower EE. Repository corticotropin for Chronic Pulmonary Sarcoidosis. Lung. 2017 Jun;195(3):313-322. doi: 10.1007/s00408-017-9994-4. Epub 2017 Mar 28.
PubMed 28353116
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
- ClinicalTrials.gov ID
- NCT02188017
- Acronym / sponsor ID
- ACPS / ACPS
- Conditions
- Sarcoidosis, Pulmonary Sarcoidosis
- Keywords
- prednisone, methotrexate, sarcoidosis, azathioprine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Jul 2014 (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.
An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.
Detailed description
This is a multi-center double-blind trial to determine dose and effect size. A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States.
After initial evaluation, including pulmonary function, CT and PET scanning, patients will be randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80 units of Acthar gel twice a week for an additional 22 weeks.
At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80 units | Active comparator | Drug: Acthar gel80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading |
| 40 units | Active comparator | Drug: Acthar gel40 units of ACTHAR gel will be given twice a week for 22 weeks after loading |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23
- Patient on >5 mg prednisone for pulmonary indications
- FVC <85% predicted
- Prednisone dose not reduced in prior 3 months
- Deterioration of pulmonary disease over the past year
Key exclusion criteria (17 listed)
- adrenal insufficiency (Addison's disease)
- Scleroderma
- a fungal infection
- herpes infection of the eyes
- osteoporosis
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 |
|---|---|---|
| Acthar gelAlso: ACTH, CortysinGiven 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week | Drug | 40 units, 80 units |
Primary outcome
Steroid toxicity
Time frame: 24 weeks
Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire
4 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: 24 weeks
Chest x-ray
Time frame: 24 weeks
PET scan
Time frame: 24 weeks
Sarcoidosis Health Questionnaire
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 8 Dec 2015.
- Derived from this study: PubMed 28353116Baughman RP, Sweiss N, Keijsers R, Birring SS, Shipley R, Saketkoo LA, Lower EE. Repository corticotropin for Chronic Pulmonary Sarcoidosis. Lung. 2017 Jun;195(3):313-322. doi: 10.1007/s00408-017-9994-4. Epub 2017 Mar 28.
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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.
Robert P Baughman, MD principal investigator
University of Cincinnati
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 gel in people with Sarcoidosis and Pulmonary Sarcoidosis, run by University of Cincinnati 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 7 inclusion and 17 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 8 Dec 2015. 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?
Contact Robert P Baughman, MD (513-58405225, bob.baughman@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid toxicity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188017, which also lists 1 linked publication.
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 8 Dec 2015.