Last updated: 06/12/2025 07:40:19

Collaborative Evaluation with United Rheumatology: Rheumatologist and Patient Perspectives on the Application of Nucala in EGPA Management

GSK study ID

221606

Clinicaltrials.gov ID

Not applicable

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Recruiting

Recruiting

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: Rheumatologists and Patient Perceptions of Nucala in EGPA: Collaboration with United Rheumatology

Trial description: "This study aims to explore the practical experiences and viewpoints of rheumatologists in prescribing treatments for eosinophilic granulomatosis with polyangiitis (EGPA). Furthermore, due to the limited knowledge about participants interactions with mepolizumab in this uncommon disease group, the study will also investigate the real-world treatment experiences of EGPA participants. The main goal of the physician survey is to outline the experiences of rheumatologists in prescribing and treating EGPA participants with mepolizumab. The primary aim of the patient survey is to detail the participants experiences (such as administration and adherence) and their satisfaction levels with mepolizumab (among those who have used mepolizumab)."

Primary purpose:

Not applicable

Trial design:

Not applicable

Masking:

Not applicable

Allocation:

Not applicable

Primary outcomes:

Number of rheumatologists who report prescribing mepolizumab within the last 12 months to induce remission of non-severe EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists who report prescribing mepolizumab within the last 12 months to maintain remission of non-severe EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists who report prescribing mepolizumab within the last 12 months to resolve relapse or refractory disease of non-severe EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported level of familiarity with mepolizumab as a treatment for EGPA (extremely familiar, very familiar, somewhat familiar, not very familiar, not very familiar at all)

Timeframe: Up to approximately 6 months

Number of rheumatologists who report prescribing mepolizumab to treat any condition within 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists who report prescribing mepolizumab to treat any condition more than 12 months ago

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported conditions for which they prescribed mepolizumab

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported doses of mepolizumab that they prescribed for participants with EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported factors influencing their decision to prescribe mepolizumab for participants with EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported reasons why their participants have continued using mepolizumab

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported reasons why their participants have stopped using mepolizumab

Timeframe: Up to approximately 6 months

Number of participants categorized by their reported satisfaction with mepolizumab in managing EGPA symptoms (completely satisfied, quite satisfied, moderately satisfied, a little satisfied, not at all satisfied)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported location where they receive mepolizumab administration (at home, doctor’s office or clinic, somewhere else)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported convenience of mepolizumab administration (very inconvenient, somewhat inconvenient, neutral, somewhat convenient, very convenient)

Timeframe: Up to approximately 6 months

Mean number of doses of mepolizumab taken by the participants within the last 12 months

Timeframe: Up to approximately 6 months

Number of participants categorized by reported reasons for delayed or missed doses of mepolizumab

Timeframe: Up to approximately 6 months

Number of participants categorized by reported time since discontinuation of mepolizumab (less than 6 months ago, 6 months to 12 months ago, 1 year to 3 years ago, more than 3 years ago)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported reasons for discontinuation of mepolizumab

Timeframe: Up to approximately 6 months

Number of participants categorized by reported impact of mepolizumab on their quality of life (significantly improved, somewhat improved, no change, somewhat worsened, significantly worsened)

Timeframe: Up to approximately 6 months

Secondary outcomes:

Number of rheumatologists categorized by reported familiarity with the ACR treatment guidelines for EGPA (extremely familiar, very familiar, somewhat familiar, not very familiar, not familiar at all)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported frequency with which they monitor participants with EGPA for disease activity and treatment response (every month, every 3 months, every 6 months, annually)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported complications that are a priority in the treatment of participants with EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported agreement level on the effectiveness of mepolizumab for induction of remission for non-severe EGPA (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported agreement level on the effectiveness of mepolizumab for maintenance of remission for non-severe EGPA (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported agreement level on the effectiveness of mepolizumab for resolving relapse or refractory disease of non-severe EGPA (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effect of mepolizumab on participants’ quality of life (no effect, minimal effect, moderate effect, great effect)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to azathioprine for maintaining remission of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to benralizumab for inducing remission of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to rituximab for inducing remission of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to benralizumab for maintaining remission of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to rituximab for maintaining remission of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to benralizumab for resolving relapse or refractory disease of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported effectiveness of mepolizumab relative to rituximab for resolving relapse or refractory disease of non-severe EGPA (much less, less, similar, more, much more, not familiar enough with either to answer)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported challenges they most frequently encounter in the management of participants with EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported degree to which each response option is a barrier to recommending mepolizumab to a participant with EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have any experience prescribing treatments for EGPA (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have prescribed treatment to induce remission of non-severe EGPA within the last 12 months (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported medications they prescribed to induce remission of non-severe EGPA within the last 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have prescribed treatment to maintain remission of non-severe EGPA within the last 12 months (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported medications they prescribed to maintain remission of non-severe EGPA within the last 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have prescribed treatment for relapsing, non-severe EGPA within the last 12 months (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported medications they prescribed to resolve relapse or refractory disease of non-severe EGPA within the last 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have prescribed treatment to induce remission of active, severe EGPA within the last 12 months (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported medications they prescribed to induce remission of active, severe EGPA within the last 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have prescribed treatment to maintain remission of severe EGPA within the last 12 months (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported medications they prescribed to maintain remission of severe EGPA within the last 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by whether they have prescribed treatment for relapsing, severe EGPA within the last 12 months (yes or no)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported medications they prescribed to resolve severe relapse of EGPA or refractory and severe EGPA within the last 12 months

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported methods they typically use to monitor the effectiveness of treatment in participants with EGPA

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported frequency of collaboration with pulmonologists or allergists/immunologists, nephrologists, hematologists, or primary care physicians when managing participants with EGPA (never, sometimes, often)

Timeframe: Up to approximately 6 months

Number of rheumatologists categorized by reported degree to which they believe participants with EGPA are involved with treatment decisions related to their EGPA (very involved, somewhat involved, not very involved, not involved at all)

Timeframe: Up to approximately 6 months

Mean age at which participants first experienced symptoms of EGPA

Timeframe: Up to approximately 6 months

Mean age at which participants were first diagnosed by a doctor with EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by reported symptoms that prompted them to go see a doctor before being diagnosed with EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by reported challenges to their diagnoses of EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by reported type of doctor who diagnosed them with EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by reported type of doctor whom they see at least once a year to manage their EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by reported duration for which they have been treated for EGPA by their rheumatologist (less than 6 months, 6 months to 1 year, 1 year to 3 years, more than 3 years)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported severity of EGPA (mild, moderate, severe)

Timeframe: Up to approximately 6 months

Number of participants categorized by whether they have experienced EGPA symptoms in the past 3 months (yes or no)

Timeframe: Up to approximately 6 months

Number of participants categorized by current reported EGPA status (active, in remission, relapsed, I do not know)

Timeframe: Up to approximately 6 months

Number of participants categorized by whether a doctor has ever diagnosed them with refractory EGPA or EGPA that is resistant to usual treatments or medications (yes, no, I do not know)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported medications they have used for EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by whether they are currently taking the medication they reported using for treating EGPA (yes or no)

Timeframe: Up to approximately 6 months

Number of participants categorized by whether they are currently taking mepolizumab for treating EGPA (yes or no)

Timeframe: Up to approximately 6 months

Number of participants categorized by whether they have taken mepolizumab in the past (yes, no, I do not know)

Timeframe: Up to approximately 6 months

Number of participants categorized by the duration for which they reported taking their current medication for EGPA (less than 6 months, 6 months to 1 year, 1 year to 3 years, more than 3 years)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported impact of EGPA on their quality of life (no impact, low impact, medium impact, high impact)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported level of satisfaction with their current quality of life, considering EGPA diagnosis and treatment (very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported areas of their life most negatively impacted by EGPA (physical health, emotional wellbeing, social interactions, daily activities and routines, work or school performance, other, none of the above)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported overall health rating (excellent, very good, good, fair, poor)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported level of difficulty faced when talking to their doctor about their EGPA symptoms and concerns (not difficult at all, somewhat difficult, very difficult, not able to explain my symptoms or concerns at all)

Timeframe: Up to approximately 6 months

Number of participants categorized by their reported level of involvement in making treatment decisions for their EGPA (I am very involved, I am somewhat involved, I am not involved at all)

Timeframe: Up to approximately 6 months

Number of participants categorized by reported factors they considered when making treatment decisions for their EGPA

Timeframe: Up to approximately 6 months

Number of participants categorized by reported degree to which each response option is a barrier to taking mepolizumab for their EGPA

Timeframe: Up to approximately 6 months

Interventions:

Not applicable

Enrollment:

100

Primary completion date:

2025-30-09

Observational study model:

Other

Time perspective:

Cross-Sectional

Clinical publications:

Not applicable

Medical condition

Eosinophilic Granulomatosis with Polyangiitis

Product

Not applicable

Collaborators

Not applicable

Study date(s)

December 2024 to September 2025

Type

Observational

Phase

Not applicable

Participation criteria

Sex

Female & Male

Age

18+ years

Accepts healthy volunteers

No

Inclusion Criteria for Physicians:
Be a licensed rheumatologist physician (Doctor of Medicine [MD] or Doctor of Osteopathic Medicine [DO]) who practices in the United States (US) in a community-based rheumatology practice.

Exclusion Criteria for Physicians:
Works in a state where physician compensation requirements differ from the Federal Sunshine Act (i.e., Vermont, Maine, Minnesota, or Massachusetts).

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status

Recruiting

Actual primary completion date

Not applicable

Actual study completion date

Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Additional information

Not applicable

Participate in clinical trial

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