Rheumatoid ArthritisNCT02030028
ACTH Gel Therapy in Rheumatoid Arthritis
A study testing ACTHAR gel in people with Rheumatoid Arthritis, run by Dana Ascherman at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ACTHAR gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year of age and older
- RA diagnosis by American College of Rheumatology criteria
- Active disease (CDAI > 10)
- Have received at least are biologic agent for at least 6 months
- May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
- No current active infections requiring antibiotics
- Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)
Who cannot join
- Less than 18 years of age
- Unable or unwilling to give Informed Consent
- Have an active infection requiring the use of antibiotics
- Women who are pregnant
- Uncontrolled hypertension
- Abnormal renal function
- Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.
ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.
Read the detailed description
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ACTHAR gel
- Keywords
- Rheumatoid Arthritis, ACTH gel
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTHAR gelDrug
Also called Adrenocorticotropic hormone
Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ACTHAR Gel | Other | Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week. Receives: Drug: ACTHAR gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
Measured: 12 weeks
Secondary outcomes (4)
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement.
Scale: 0-8.61 (lower scores indicate reduced disease activity)
Measured: 12 weeks
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP < 0))
Measured: 12 weeks
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0)
Measured: 12 weeks
Patient Reported Changes in Fatigue Between Week 0 and Week 12
The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startNov 2014
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana Ascherman
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Dana Ascherman, University of Pittsburgh
- Investigators
- Larry W Moreland, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030028
- Sponsor's protocol ID
- STUDY19050342
- Status last verified
- Aug 2023
- First submitted
- 6 Jan 2014
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02030028
- Acronym / sponsor ID
- STUDY19050342
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, ACTH gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dana AschermanUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Nov 2014
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 6 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.
ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.
Detailed description
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTHAR Gel | Other | Drug: ACTHAR gelOpen label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 year of age and older
- RA diagnosis by American College of Rheumatology criteria
- Active disease (CDAI > 10)
- Have received at least are biologic agent for at least 6 months
- May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
Key exclusion criteria (7 listed)
- Less than 18 years of age
- Unable or unwilling to give Informed Consent
- Have an active infection requiring the use of antibiotics
- Women who are pregnant
- Uncontrolled hypertension
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: Adrenocorticotropic hormoneSubjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks. | Drug | ACTHAR Gel |
Primary outcome
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
Time frame: 12 weeks
percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
4 secondary outcomes
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
Time frame: 12 weeks
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
Time frame: 12 weeks
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Time frame: 12 weeks
Patient Reported Changes in Fatigue Between Week 0 and Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Larry W Moreland, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTHAR gel in people with Rheumatoid Arthritis, run by Dana Ascherman 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 7 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 6 Sep 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 (time frame: 12 weeks). 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 6 Sep 2023.