Rheumatoid ArthritisPhase 4NCT01966718

Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

A Phase 4 study testing Repository corticotropin injection in people with Rheumatoid Arthritis, run by Arthritis Treatment Center, Maryland at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Repository corticotropin injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Oct 2015
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Rheumatoid arthritis of at least 2 years duration
On at least third biologic with a different mechanism of action for at least 12 weeks
Active disease as defined by at least 6 tender and 6 swollen joints
Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal
Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks

Who cannot join

Prior treatment with Acthar Gel
History of intolerance or allergy to glucocorticoids
Unstable diabetes
Active infection

Trial locations and contacts

1 site in 1 country.

United States1 site

Arthritis Treatment Center
Frederick, Maryland, 21702

Other trials in United States

About this study

Official title: Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action

Read the detailed description

Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.

Conditions: Rheumatoid Arthritis
Being tested: Repository corticotropin injection
Keywords: Rheumatoid arthritis, Joint pain, Repository corticotropin injection
Medical subject headings: Arthritis, Rheumatoid, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repository corticotropin injectionDrug
Also called H. P. Acthar Gel
An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances

Study groups in NCT01966718
Study group	Role	What they receive
Repository corticotropin injection	Experimental	Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks Receives: Drug: Repository corticotropin injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Ritchey-Camp Articular Index
Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.
Measured: From baseline to week 16
Change From Baseline in the 20-item Health Assessment Questionnaire Score
Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.
Measured: From baseline to week 16

Secondary outcomes (2)

Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased
Measured: From baseline to week 16
Change From Baseline in the C-Reactive Protein (CRP) Level
CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.
Measured: From baseline to week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Oct 2015

First posted22 Oct 2013 (estimated)
Study startOct 2013
Primary completionOct 2015
Study completionOct 2015

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01966718
Sponsor's protocol ID: ATC 005
Status last verified: Jul 2016
First submitted: 14 Oct 2013
Last updated: 18 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action
ClinicalTrials.gov ID: NCT01966718
Acronym / sponsor ID: ATC 005
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis, Joint pain, Repository corticotropin injection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Arthritis Treatment Center, MarylandUniversity, hospital or other
Study start: Oct 2013
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 22 Oct 2013 (estimated)
Results: Posted 18 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Repository corticotropin injection	Experimental	Drug: Repository corticotropin injectionRepository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Rheumatoid arthritis of at least 2 years duration
On at least third biologic with a different mechanism of action for at least 12 weeks
Active disease as defined by at least 6 tender and 6 swollen joints
Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal
Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks

Key exclusion criteria (4 listed)

Prior treatment with Acthar Gel
History of intolerance or allergy to glucocorticoids
Unstable diabetes
Active infection

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
Repository corticotropin injectionAlso: H. P. Acthar GelAn adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances	Drug	Repository corticotropin injection

Primary outcome

Change From Baseline in the Ritchey-Camp Articular Index
Time frame: From baseline to week 16
Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.
Change From Baseline in the 20-item Health Assessment Questionnaire Score
Time frame: From baseline to week 16
Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.

2 secondary outcomes

Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
Time frame: From baseline to week 16
Change From Baseline in the C-Reactive Protein (CRP) Level
Time frame: From baseline to week 16

Results and safety

Results posted to the registry on 18 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Repository Corticotropin Injection	8	8

Primary outcome: Change From Baseline in the Ritchey-Camp Articular Index

Time frame: From baseline to week 16. Mean (Full Range). Unit: joints

Measure	Swollen Joints n = 8	Tender Joints n = 8
Value	10.25 (-1 to 35)	9 (-17 to 31)

Primary outcome: Change From Baseline in the 20-item Health Assessment Questionnaire Score

Time frame: From baseline to week 16. Mean (Full Range). Unit: units on a scale

Measure	Repository Corticotropin Injection n = 8
Value	0.03 (-0.5 to 0.25)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected at each visit (two to six week intervals) up to week 16. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Repository Corticotropin Injection	1 of 8 (12.5%)	6 of 8 (75%)	Not reported

Limitations and caveats (from the sponsor): Small sample size (8 patients); Open label, Sampling bias cannot be excluded;Single group study; no standardization of concomitant therapy

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Nathan Wei, MD principal investigator

Nathan Wei, MD dba Arthritis Treatment Center, Frederick, MD 21702 USA

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 Repository corticotropin injection in people with Rheumatoid Arthritis, run by Arthritis Treatment Center, Maryland 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 5 inclusion and 4 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 18 Aug 2016. 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?

Yes. Results are posted in the registry (first posted 18 Aug 2016). 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?

Change From Baseline in the Ritchey-Camp Articular Index (time frame: From baseline to week 16). 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?

On the ClinicalTrials.gov record for NCT01966718.

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 18 Aug 2016.