Lupus Erythematosus, SystemicPhase 4RIFLENCT03098823
A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
A Phase 4 study testing RAYOS and Prednisone in people with Lupus Erythematosus, Systemic and Lupus Erythematosus, run by Ampel BioSolutions, LLC at 21 sites in United States.
Trial summary
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Fatigue
- What is being tested?
- RAYOS and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 21 sitesUnited States
- Study dates
- 12 Sep 2017to 15 Jun 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent agreeing to all study procedures, before any study-specific procedures are done.
- Males or non-pregnant females, aged 18 years or older
- Diagnosis of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria
- Fatigue measured by FACIT-F ≤30.
- On a stable regimen of IR prednisone (5 to 15 mg/day) for a period of at least 30 days prior to Screening, expected to remain stable for the next 6 months.
- On a stable SLE treatment regimen for a period of at least 30 days prior to Screening, and expected to remain stable for the next 6 months. Any of the following medications are permitted if stable for at least 30 days prior to Screening and expected to remain stable for the next 6 months:
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- Hydroxychloroquine or equivalent anti-malarial
- Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate sodium or mycophenylate mofetil at no more than 2 grams/day), belimumab, cyclophosphamide, calcineurin inhibitors (e.g. tacrolimus, cyclosporine)
- Entry of daily ePRO data on 11 of 14 days during the baseline period, and completion of at least 6 out of the 8 weekly ePRO questionnaires during the baseline period
- Willing and able to perform and comply with all study procedures, including taking pills daily as prescribed, completing the ePROs on the smart phone, wearing the smart watch day and night, bringing the smartphone on all activities away from home (e.g., walks, errands, visiting, shopping, traveling), keeping the smartphone and smartwatch charged daily, carefully using the smartphone and smartwatch as clinical tools and keeping them secure from others, and attending monthly clinic visits as scheduled
- Females of childbearing potential must be currently using a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device, or use of a spermicide combined with a barrier method (e.g., condom, diaphragm) for 30 days before and 90 days after receiving the study drug
Who cannot join
- Previously taken any of the following medications:
- RAYOS®
- Rituximab within 6 months prior to Screening
- Any investigational therapy within 3 months or 5 half-lives of the agent prior to Screening
- History of noncompliance with taking pills as prescribed.
- Rapidly progressive neurologic disease
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- Rapidly progressive renal disease (defined by proteinuria >6 g/24 hours or equivalent using spot urine protein to creatinine ratio, or serum creatinine >2.5 mg/dL)
- Diagnosis of fibromyalgia
- Any of the following clinical laboratory abnormalities:
- Hemoglobin <8.0 mg/dL
- Platelet count <50,000/mm3
- White blood count (WBC) ≤ 2000/mm3; may be 1999-1000/mm3 if stable and related to SLE
- Absolute neutrophil count (ANC) ≤1000/mm3; may be 500-999/mm3 if stable and related to SLE
- Aspartate transaminase (AST) or alanine transaminase (ALT) ≥3× upper limit of normal (ULN) unless related to SLE
- Calculated creatinine clearance ≤25 mL/min per 1.73 m2 (by Cockcroft-Gault equation)
- Grade 3 or greater laboratory abnormality based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; Appendix 3) except for the following that are allowed:
- Activated partial thromboplastin time (PTT) > >2.5× ULN due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy
- Hypoalbuminemia <2 g/dL due to chronic lupus nephritis, and not related to liver disease
- Gamma glutamyl transferase (GGT) <20× ULN due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in the ALT and/or AST must be ≤5× ULN
- Pregnant or nursing, or females not using effective contraception
- Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 1 year prior to Screening
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not caused by SLE (e.g., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the Investigator, could confound the results of the study or put the subject at undue risk
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The MetroHealth System
Cleveland, Ohio, 44109
University of Florida College of Medicine
Gainesville, Florida, 32610
Hershey Medical Center
Hershey, Pennsylvania, 17033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Regents of the University of California, Los Angeles
Los Angeles, California, 90095
Miller School of Medicine at the University of Miami
Miami, Florida, 33136
Yale School of Medicine
New Haven, Connecticut, 06519
The Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
University of California-Irvine
Orange, California, 92868
Stanford University
Palo Alto, California, 94304
Temple University
Philadelphia, Pennsylvania, 19140
The Regents of the University of California, San Diego
San Diego, California, 92037
University of California-San Francisco
San Francisco, California, 94143
UMASS Memorial Medical Center-Memorial Campus
Worcester, Massachusetts, 01605
About this study
Official title: A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Fatigue
- Being tested
- RAYOS, Prednisone
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAYOSDrug
FDA approved RAYOS for indication of fatigue in Lupus.
PrednisoneDrug
FDA approved corticosteroid frequently used for SLE.
| Study group | Role | What they receive |
|---|---|---|
| RAYOS® | Experimental | Not described Receives: Drug: RAYOS |
| IR prednisone | Active comparator | Not described Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue as measured in FACIT-F by patient
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start12 Sep 2017
- Primary completion28 May 2019
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ampel BioSolutions, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098823
- Sponsor's protocol ID
- AMP-002
- Acronym
- RIFLE
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2017
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03098823
- Acronym / sponsor ID
- RIFLE / AMP-002
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ampel BioSolutions, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAYOS® | Experimental | Drug: RAYOS |
| IR prednisone | Active comparator | Drug: Prednisone |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent agreeing to all study procedures, before any study-specific procedures are done.
- Males or non-pregnant females, aged 18 years or older
- Diagnosis of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria
- Fatigue measured by FACIT-F ≤30.
- On a stable regimen of IR prednisone (5 to 15 mg/day) for a period of at least 30 days prior to Screening, expected to remain stable for the next 6 months.
Key exclusion criteria (22 listed)
- Previously taken any of the following medications:
- History of noncompliance with taking pills as prescribed.
- Rapidly progressive neurologic disease
- Rapidly progressive renal disease (defined by proteinuria >6 g/24 hours or equivalent using spot urine protein to creatinine ratio, or serum creatinine >2.5 mg/dL)
- Diagnosis of fibromyalgia
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 |
|---|---|---|
| RAYOSFDA approved RAYOS for indication of fatigue in Lupus. | Drug | RAYOS® |
| PrednisoneFDA approved corticosteroid frequently used for SLE. | Drug | IR prednisone |
Primary outcome
Fatigue
Time frame: 3 months
Fatigue as measured in FACIT-F by patient
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 8 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RAYOS and Prednisone in people with Lupus Erythematosus, Systemic and Lupus Erythematosus, run by Ampel BioSolutions, LLC at 21 sites 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 11 inclusion and 22 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 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
Fatigue (time frame: 3 months). 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 8 Jul 2020.