MyositisPhase 2/3BIMNCT02347891

Belimumab in Idiopathic Inflammatory Myositis

A Phase 2/3 study testing Belimumab in people with Myositis, run by Northwell Health at 1 site in United States.

Completed

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

Trial summary

The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care. This is a multicentre double-blind, placebo-controlled trial. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myositis
What is being tested?: Belimumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Nov 2020
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects enrolled in the study must meet the following inclusion criteria:
Adults >18 years of age
Have a diagnosis of:
definite or probable dermatomyositis (DM) or
Definite or probable diagnosis of polymyositis (PM) with presence of one of myositis specific antibodies. In the absence of myositis specific auto-antibodies, the diagnosis of PM will require review of the muscle biopsy and adjudication by the predetermined committee of experts.
Presence of positive autoantibody (ANA >1:80 or RNP or SSA/SSB or any of the myositis specific autoantibody: antisynthetase autoantibodies (anti-Jo-1, PL-7, PL-12, EJ, OJ, KS), anti-SRP, anti-Mi-2, anti-p140).

Show all 19Show fewer

Have refractory IIM as defined by inadequate response or intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive agent, such as azathioprine, methotrexate, IVIG, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine cyclophosphamide, and Rituximab.
Have active IIM at screening. This requires at least 3 criteria from the CSM
Dermatomyositis patients that do not meet the MMT criteria, must have:
a cutaneous VAS score of >3 cm on a 10 cm VAS scale (MDAAT) will be required:
elevation of at least one muscle enzyme (creatine kinase [CK]; aldolase; lactate dehydrogenase [LDH]; alanine aminotransferase [ALT]; or aspartate aminotransferase [AST]) to a minimum level of 1.3 times the upper limit of normal,
and 1 additional core set measure
For patients with ≥ 7 years of IIM, muscle biopsy or muscle MRI within 4 months prior to enrollment will be required to document active myositis to avoid enrolling patients with significant index of damage/ muscle atrophy. This is not applicable to DM patients with a cutaneous VAS score of >3 cm on a 10 cm VAS scale (MDAAT).
Have a stable background glucocorticoid therapy for at least 2 weeks prior to screening (Prednisone (or equivalent) dose < 15 mg daily)
Have a stable immunosuppressive therapy (IS) (azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine for > 2 months prior to screening. Patients on intravenous gamma globulin (IVIG) have to be on a stable dose and frequency regimen for ≥ 3 months.
Have the ability to understand the requirements of the study and provide written informed consent (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits)
Female subjects of childbearing potential must have a negative urine pregnancy test at screening and agree to 1 of the following:
Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception); or
Consistent and correct use of 2 of acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 16 weeks after the last dose of study agent

Who cannot join

Subjects meeting any of the following criteria will be excluded from the study:
Have severe muscle damage as defined by a Muscle Damage Index (MDI) > 5.0 cm using a visual analogue scale (VAS) 10.0 cm in length or evidence of severe muscle atrophy on muscle MRI.
History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell).
Have a history of a primary immunodeficiency
Have a significant IgG deficiency (IgG level < 400 mg/dl) Have an IgA deficiency (IgA level < 10 mg/dL)
Discontinuation IS agent < 3 months prior to Screening. Including: azathioprine, methotrexate, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, or intravenous gamma globulin [IVIG]

Show all 28Show fewer

Have received Rituximab within 365 days prior to Screening.
Have received cyclophosphamide within 180 days prior to Screening
Have received treatment with:
Initiated IVIG 3 months prior to Screening
Pulse steroids 2 months prior to Screening
Have received treatment with Belimumab at any time prior to Screening
Have received a biologic investigational agent within 365 days prior to Screening.
Have received a non-biologic investigational agent within 30 days or 5 half-lives of the agent (whichever is longer) prior to Screening.
Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
Infection history:
Currently on any suppressive therapy for a chronic infection (such as tuberculosis - including latent tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
NOTE: Testing for latent TB is a standard of care for patients on immunosuppressive therapy and results will be obtained from their medical record. If no TB history is found for these patients, a Quantiferon Gold or PPD test will be performed prior to Day 0 as part of standard of care.
Hospitalization for treatment of infection within 60 days of Day 0.
Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0.
Have a historically positive HIV test or test positive at screening for HIV.
Have a history of autoimmune hepatitis
Hepatitis status will be obtained from patients' medical records. If unavailable, testing will be done as part of standard of care. Patients are excluded if there is evidence of infection with:
Hepatitis B: i. Positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) or b. Hepatitis C: i. Positive hepatitis C antibody with confirmatory hepatitis C viral load by PCR.
Clinically significant elevation of GGT (>1.5xULN), bilirubin (>1.25xULN, direct 35%), or INR (>1.2, excluding patients on anti-coagulant therapies) or other clinically significant abnormal laboratory value in the opinion of the investigator.
Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
Have any concurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwell Health Divison of Rheumatology
Great Neck, New York, 11021

Other trials in United States

About this study

Official title: Belimumab for Maintenance Therapy in Idiopathic Inflammatory Myositis

Read the detailed description

Adults with refractory IIM will be enrolled. IIM is defined as Dermatomyositis (DM) or Polymyositis (PM), meeting the Bohan \& Peter (1975) diagnostic criteria for definite or probable DM or PM. Refractory IIM is defined as chronic active IIM with a history of inadequate response or intolerance to three months of glucocorticoids and/or at least a history of inadequate response or intolerance to three months of one other immunosuppressive agent (IS) (azathioprine, methotrexate, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, cyclophosphamide, Rituximab or intravenous gamma globulin [IVIG]).

Conditions: Myositis
Being tested: Belimumab, Placebo
Keywords: Inflammatory Myositis, Dermatomyositis, Polymyositis, Muscle Pain, Myositis, Refractory myositis
Medical subject headings: Myositis, Dermatomyositis, Polymyositis, Myalgia

What participants receive

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

BelimumabDrug
Also called Benlysta
Randomized phase: Week 0 - Week 40
PlaceboDrug
Also called Saline IV bag
Randomized phase: Week 0 - Week 40

Study groups in NCT02347891
Study group	Role	What they receive
Belimumab + Standard of Care	Experimental	Patients in this arm will be given belimumab with a background of standard of care therapy during the randomized controlled treatment period. Patients in this arm will continue to receive belimumab during the open label phase of the study (week 40 - week 64) Receives: Drug: Belimumab
Placebo + Standard of Care	Active comparator	Patients in this arm will be given a placebo with a background of standard of care therapy during the randomized controlled treatment period. Patients in this arm will receive belimumab during the open label phase of the study (week 40 - week 64). Receives: Drug: Placebo

What is being measured

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

Response Rate During Randomized Phase
Definition of Improvement (DOI) is ≥ 20% of improvement in any 3 of the core set measures (CSM) - Manual Muscle Testing, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra- muscular activity and no more than 2 CSM worsening by ≥ 25% (excluding MMT).
Total Improvement Score ( TIS) is a sum of weighted scores of absolute change of core set measures ( MMT, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra-muscluar activity ). The scores range from 0 to 100, with higher scores indicating greater improvement. TIS ≥ 40 indicates a moderate response and ≥ 60 TIS indicates a major response.
Measured: 40 weeks
Mean Total Improvement Score (TIS) During Randomized Phase
It is a composite measure calculated as a sum of weighted scores assigned to absolute changes for each measure (MMT , Patient Global, Physician Global, Muscle enzymes, Extramuscluar activity and HAQ) . Total score could range from 0 to 100. TIS ≥ 20 indicates minimal improvement, TIS ≥ 40 indicates moderate response and TIS ≥ 60 indicates a major response.
2016 ACR/EULAR Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016)
Measured: 40 Week

Secondary outcomes (2)

Response Rate After Open Label Phase
It is a composite measure calculated as a sum of weighted scores assigned to absolute changes for each measure (MMT , Patient Global, Physician Global, Muscle enzymes, Extramuscluar activity and HAQ) . Total score could range from 0 to 100. TIS ≥ 20 indicates minimal improvement, TIS ≥ 40 indicates moderate response and TIS ≥ 60 indicates a major response.
2016 ACR/EULAR Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016)
Measured: 64 weeks
Mean Total Improvement Score (TIS) After Open Label Phase
Definition of Improvement (DOI) is ≥ 20% of improvement in any 3 of the core set measures (CSM) - Manual Muscle Testing, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra- muscular activity and no more than 2 CSM worsening by ≥ 25% (excluding MMT).
Total Improvement Score ( TIS) is a sum of weighted scores of absolute change of core set measures ( MMT, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra-muscluar activity ). The scores range from 0 to 100, with higher scores indicating greater improvement. TIS ≥ 40 indicates a moderate response and ≥ 60 TIS indicates a major response. Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016)
Measured: 64 Week

Timeline

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

Jan 2015Nov 2020

First posted28 Jan 2015 (estimated)
Study startJan 2015
Primary completionNov 2020
Study completionNov 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MyositisStudies of the same condition, open and under way.
More trials run by Northwell HealthThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347891
Sponsor's protocol ID: 14-621
Acronym: BIM
Status last verified: Jan 2024
First submitted: 22 Jan 2015
Last updated: 9 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Marder G, Quach T, Chadha P, Nandkumar P, Tsang J, Levine T, Schiopu E, Furie R, Davidson A, Narain S. Belimumab treatment of adult idiopathic inflammatory myopathy. Rheumatology (Oxford). 2024 Mar 1;63(3):742-750. doi: 10.1093/rheumatology/kead281.
PubMed 37326854

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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All Myositis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Belimumab for Maintenance Therapy in Idiopathic Inflammatory Myositis
ClinicalTrials.gov ID: NCT02347891
Acronym / sponsor ID: BIM / 14-621
Conditions: Myositis
Keywords: Inflammatory Myositis, Dermatomyositis, Polymyositis, Muscle Pain, Myositis, Refractory myositis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jan 2015 (actual)
Primary completion: Nov 2020 (actual)
Study completion: Nov 2020 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 9 Feb 2024

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Belimumab + Standard of Care	Experimental	Drug: BelimumabPatients in this arm will be given belimumab with a background of standard of care therapy during the randomized controlled treatment period. Patients in this arm will continue to receive belimumab during the open label phase of the study (week 40 - week 64)
Placebo + Standard of Care	Active comparator	Drug: PlaceboPatients in this arm will be given a placebo with a background of standard of care therapy during the randomized controlled treatment period. Patients in this arm will receive belimumab during the open label phase of the study (week 40 - week 64).

Who may qualify

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

Key inclusion criteria (19 listed)

Adults >18 years of age
Have a diagnosis of:
Presence of positive autoantibody (ANA >1:80 or RNP or SSA/SSB or any of the myositis specific autoantibody: antisynthetase autoantibodies (anti-Jo-1, PL-7, PL-12, EJ, OJ, KS), anti-SRP, anti-Mi-2, anti-p140).
Have refractory IIM as defined by inadequate response or intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive agent, such as azathioprine, methotrexate, IVIG, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine cyclophosphamide, and Rituximab.
Have active IIM at screening. This requires at least 3 criteria from the CSM

Key exclusion criteria (28 listed)

Have severe muscle damage as defined by a Muscle Damage Index (MDI) > 5.0 cm using a visual analogue scale (VAS) 10.0 cm in length or evidence of severe muscle atrophy on muscle MRI.
History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell).
Have a history of a primary immunodeficiency
Have a significant IgG deficiency (IgG level < 400 mg/dl) Have an IgA deficiency (IgA level < 10 mg/dL)
Discontinuation IS agent < 3 months prior to Screening. Including: azathioprine, methotrexate, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, or intravenous gamma globulin [IVIG]

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
BelimumabAlso: BenlystaRandomized phase: Week 0 - Week 40	Drug	Belimumab + Standard of Care
PlaceboAlso: Saline IV bagRandomized phase: Week 0 - Week 40	Drug	Placebo + Standard of Care

Primary outcome

Response Rate During Randomized Phase
Time frame: 40 weeks
Definition of Improvement (DOI) is ≥ 20% of improvement in any 3 of the core set measures (CSM) - Manual Muscle Testing, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra- muscular activity and no more than 2 CSM worsening by ≥ 25% (excluding MMT). Total Improvement Score ( TIS) is a sum of weighted scores of absolute change of core set measures ( MMT, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra-muscluar activity ). The scores range from 0 to 100, with higher scores indicating greater improvement. TIS ≥ 40 indicates a moderate response and ≥ 60 TIS indicates a major response.
Mean Total Improvement Score (TIS) During Randomized Phase
Time frame: 40 Week
It is a composite measure calculated as a sum of weighted scores assigned to absolute changes for each measure (MMT , Patient Global, Physician Global, Muscle enzymes, Extramuscluar activity and HAQ) . Total score could range from 0 to 100. TIS ≥ 20 indicates minimal improvement, TIS ≥ 40 indicates moderate response and TIS ≥ 60 indicates a major response. 2016 ACR/EULAR Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016)

2 secondary outcomes

Response Rate After Open Label Phase
Time frame: 64 weeks
Mean Total Improvement Score (TIS) After Open Label Phase
Time frame: 64 Week

Results and safety

Results posted to the registry on 9 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase)	10	8
Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase)	7	6

Primary outcome: Response Rate During Randomized Phase

Time frame: 40 weeks. Count of participants. Unit: Participants

Measure	Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) n = 9	Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) n = 6
Week 40 : Definition of Improvement (DOI)	3	1
Week 40 : Percent patients reaching Total improvement score of ≥40	5	2
Week 40 : Percent of patient with major improvement TIS ≥60	2	0

Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) vs Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase): Risk Ratio (RR): 0.5 (95% CI 0.08 to 2.65), p = 0.60, ANOVA
Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) vs Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase): Risk Ratio (RR): 0.6 (95% CI 0.16 to 1.82), p = 0.61, ANOVA
Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) vs Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase): Risk Ratio (RR): 0 (95% CI 0 to 1.47), p = 0.23, ANOVA

Primary outcome: Mean Total Improvement Score (TIS) During Randomized Phase

Time frame: 40 Week. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) n = 9	Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) n = 6
Value	38.8 (24.9)	37.9 (5.8)

Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) vs Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase): p = 0.92, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was collected on all enrolled patients from the time of enrollment till last study visit up to 64 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 (Belimumab + SoC (Randomized Phase)	1 of 10 (10%)	5 of 10 (50%)	6 of 10
Arm 2 (Placebo + SoC (Randomized Phase)	0 of 7 (0%)	6 of 7 (85.7%)	6 of 7
Open Label Arm 1 and 2 Combined	0 of 14 (0%)	6 of 14 (42.9%)	6 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37326854Marder G, Quach T, Chadha P, Nandkumar P, Tsang J, Levine T, Schiopu E, Furie R, Davidson A, Narain S. Belimumab treatment of adult idiopathic inflammatory myopathy. Rheumatology (Oxford). 2024 Mar 1;63(3):742-750. doi: 10.1093/rheumatology/kead281.
Individual participant dataSharing planned: Undecided

Related trials for Myositis

RecruitingPhase 2
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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.

Galina Marder, MD principal investigator

Northwell.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Belimumab in people with Myositis, run by Northwell Health 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 19 inclusion and 28 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 9 Feb 2024. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 9 Feb 2024). 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?

Response Rate During Randomized Phase (time frame: 40 weeks). 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 NCT02347891, 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 9 Feb 2024.