Last updated: 02/04/2020 15:00:09
Patient Experience and Delivery Device Preferences with Belimumab: Follow up Questionnaires and Interviews to the Belimumab Subcutaneous Autoinjector Real Life Use Study in Systemic Lupus Erythematosus (SLE)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Patient Experience and Delivery Device Preferences with Belimumab: Follow up Questionnaires and Interviews to the Belimumab Subcutaneous Autoinjector Real Life Use Study in Systemic Lupus Erythematosus (SLE)
Trial description: As a complement to the Belimumab Autoinjector Subcutaneous Real Life Use (RLU) Study (GSK 200339), this study will generate additional insight from the perspective of the patient regarding his/her experience with belimumab and preferences in administration routes using a multi-item self-reported survey. This study is a descriptive cross-sectional survey of existing belimumab patients with Systemic Lupus Erythematosus (SLE) who have already agreed to participate in the RLU study, have switched to the auto-injector, and who meet the inclusion criteria of this study. Following the last RLU study visit, qualitative and quantitative methodology will elicit patient-level insight and direct quotations from participants about important underlying concepts associated with their disease and their treatment with belimumab. The primary objectives of this study are to explore patient experiences with belimumab, in general, and with the belimumab autoinjector. Other secondary objectives are to explore the patient experiences associated with switching to the autoinjector from intravenous (IV) or pre-filled syringe, and patient preferences for administrative routes.Adult men and women who complete their RLU Study Week 8 visit will be recruited by study site personnel to complete an online, web-based Follow-up Questionnaire (with provision of a paper-based questionnaire as an alternative) within 14 days of their Week 8 clinic visit. In addition, one-on-one qualitative follow-up telephone interviews will be conducted with a subset of approximately 30 participants within 21 days of the RLU Study Week 8 visit. Prior to the completion of any study related activities, patients will engage in a multi-step consenting process. In addition, select clinical and demographic information collected in the RLU Study will be exported from the trial database.All analyses will be descriptive in nature. Descriptive statistics will be used to characterize the sample in terms of sociodemographic and clinical characteristics. The results will summarize patient experience with the autoinjector, and preferences for administration route. Specific questions regarding satisfaction with the autoinjector, pain during use, ease of use, convenience of use, and confidence while using the device, and comparisons to other belimumab administration routes will be asked. A statistical analysis plan (including table shells) will be developed to outline the methods and table shells for the quantitative data that will be collected. Content analysis will be used to analyze the qualitative data (based on audio recordings and transcripts). Responses to each question will be tabled and analyzed using a content analysis approach. Results will be tabulated and relevant quotes will be included to provide examples of patient responses.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Self-reported impact of belimumab treatment on disease symptoms, work and productivity
Timeframe: 2 weeks
Self-reported experience of taking belimumab using the auto-injector
Timeframe: 2 weeks
Self-reported satisfaction with treatment administration route (frequency, ease, convenience, discomfort, confidence
Timeframe: 2 weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2015-31-07
Observational study model:
Other
Time perspective:
Cross-Sectional
Clinical publications:
Ebony Dashiell-Aje, Gale Harding, Katie Pascoe, Jane DeVries, Pamela Berry, Sulabha Ramachandran. Patient evaluation of satisfaction and outcomes of an autoinjector for self-administration of subcutaneous belimumab for systemic lupus erythematosus. Patient. 2018;11(1):119-129
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
March 2015 to July 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Meet all of the RLU study (GSK #200339) inclusion criteria as outlined in the clinical trial protocol and below:
- - Male or female aged at least 18 years at the time of signing the informed consent.
- Has a cognitive, emotional, or behavioral impairment or a learning disability that would interfere with participating in an interview or completing the questionnaire (evaluated through clinician assessment).
Inclusion and exclusion criteria
Inclusion criteria:
- Meet all of the RLU study (GSK #200339) inclusion criteria as outlined in the clinical trial protocol and below: -- Male or female aged at least 18 years at the time of signing the informed consent. -- Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria. -- Active, autoantibody positive SLE, defined as the presence of ANA or anti-dsDNA antibodies (at screening or historically). -- Are on a SLE treatment regimen including IV belimumab every 28 days for at least three 28-day cycles. Day 0 (i.e., day of first dose of study agent) should be scheduled about 2 weeks after the last dose IV dose of belimumab but may be scheduled 1 week and up to 4 weeks after the last IV dose. OR Have completed the open-label phase of Study HGS1006-C1115 and have initiated treatment with IV belimumab. Day 0 (i.e., day of first dose of study agent) should be scheduled about 2 weeks after the last IV dose of belimumab but may be completed 1 week and up to 4 weeks after the last IV dose. OR Have completed the open-label phase of Study HGS1006-C1115 and have not initiated treatment with IV belimumab. Day 0 (i.e., day of the first dose of study agent) should be scheduled about 1 week after the last dose of study agent in Study HGS1006-C1115 but may be scheduled up to 16 weeks after the last dose of study agent in Study HGS1006-C1115. -- A female subject is eligible to participate if she is of: ---Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, “documented” refers to the outcome of the investigator's/designee’s review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 MIU/mL and estradiol <40 pg/mL (<147 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods listed in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.] OR --- Child-bearing potential with negative pregnancy test as determined by serum hCG test at screening and urine hCG test prior to dosing AND Agrees to use one of the contraception methods listed in the protocol (see Section 4.4) for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 112 days after the last dose of study agent. OR Has only same-sex partners, when this is her preferred and usual lifestyle. -- ALT <2xULN, alkaline phosphatase and bilirubin 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). -- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Currently enrolled in and completed the RLU Week 8 study visit or completed their termination visit.
- Able to speak, read, and write English sufficiently well to complete study questionnaires.
- Able to indicate that they are willing to participate in the study.
Exclusion criteria:
- Has a cognitive, emotional, or behavioral impairment or a learning disability that would interfere with participating in an interview or completing the questionnaire (evaluated through clinician assessment).
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2015-31-07
Actual study completion date
2015-31-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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