Crohn's DiseaseVITALITYNCT02451839
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
An observational study of Crohn's Disease and Rheumatoid Arthritis, run by AbbVie.
Trial summary
For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the Phase IV setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease, Rheumatoid Arthritis, Psoriasis
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2015to 5 Dec 2017
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be males and/or females who are attending a routine clinical visit and meet all of the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Patients with a diagnosis of rheumatoid arthritis, Crohn's disease or psoriasis who have made a decision with their physician to commence treatment with adalimumab in accordance with routine medical practice and with the approved adalimumab New Zealand Datasheet.
- Patients who have been evaluated for tuberculosis risk factors/exposure for active/latent tuberculosis infection (per local requirements and according to the approved adalimumab New Zealand Datasheet).
- Adult subjects, 18-75 years old, who have voluntarily signed and dated an informed consent form prior to any study-specific procedures.
Who cannot join
- Previous treatment with adalimumab.
- Previous treatment with any biologic.
- Severe infection including sepsis, active tuberculosis or opportunistic infection.
- Moderate to severe heart failure (New York Heart Association Class II/III).
- Concurrent administration with anakinra.
- Hypersensitivity to adalimumab or its excipients.
- Any condition that in the opinion of the investigator would compromise the subject's well-being or ability to perform the study requirements.
About this study
For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the Phase IV setting. There are even less data available in New Zealand, which did not have the opportunity to participate to a major extent in large, multinational, Phase III pivotal studies of adalimumab in IMIDs.
The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple, validated, free and easy-to-use generic assessment instrument for health and disability. It is applicable across cultures, in all adult populations. It is a responsive measure that can show what difference a treatment makes.
Results from study of effect of adalimumab on WHODAS scores and other patient-reported outcomes (PROs) of work activity and well-being will be of interest to a variety of stakeholders in the healthcare system including patients, healthcare practitioners and payers.
- Conditions
- Crohn's Disease, Rheumatoid Arthritis, Psoriasis
- Keywords
- Crohn Disease, Arthritis, Rheumatoid, Psoriasis, Patient Outcome Assessment, Adalimumab, Global Health, Quality of Life
- Medical subject headings
- Crohn Disease, Arthritis, Rheumatoid, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease | Participants with Crohn's disease. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. | |
| Rheumatoid Arthritis | Participants with rheumatoid arthritis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. | |
| Psoriasis | Participants with psoriasis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Measured: Baseline, Month 6
Secondary outcomes (16)
Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Measured: Baseline, Month 2
Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Measured: Baseline, Month 4
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Measured: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Measured: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Measured: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Measured: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Measured: Baseline, Month 6
Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Measured: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Measured: Baseline, Month 6
Change From Baseline in K10 at Month 6 Across All Indications
The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
Measured: Baseline, Month 6
Change From Baseline in Flourishing Scale at Month 6 Across All Indications
The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths.
Measured: Baseline, Month 6
Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition.
Measured: Baseline, Month 6
Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).
Measured: Baseline, Month 6
Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).
Measured: Baseline, Month 6
Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.
Measured: Baseline, Month 6
Number of Participants Remaining on Treatment at Month 6
The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start6 Jul 2015
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
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 Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451839
- Sponsor's protocol ID
- P15-345
- Acronym
- VITALITY
- Status last verified
- Jan 2018
- First submitted
- 20 May 2015
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gearry RB, Frampton C, Inns S, Poppelwell D, Rademaker M, Suppiah R. VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand. Curr Med Res Opin. 2019 Oct;35(10):1837-1846. doi: 10.1080/03007995.2019.1634952. Epub 2019 Jul 3.
PubMed 31233347
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
- ClinicalTrials.gov ID
- NCT02451839
- Acronym / sponsor ID
- VITALITY / P15-345
- Conditions
- Crohn's Disease, Rheumatoid Arthritis, Psoriasis
- Keywords
- Crohn Disease, Arthritis, Rheumatoid, Psoriasis, Patient Outcome Assessment, Adalimumab, Global Health, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the Phase IV setting. There are even less data available in New Zealand, which did not have the opportunity to participate to a major extent in large, multinational, Phase III pivotal studies of adalimumab in IMIDs.
The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple, validated, free and easy-to-use generic assessment instrument for health and disability. It is applicable across cultures, in all adult populations. It is a responsive measure that can show what difference a treatment makes.
Results from study of effect of adalimumab on WHODAS scores and other patient-reported outcomes (PROs) of work activity and well-being will be of interest to a variety of stakeholders in the healthcare system including patients, healthcare practitioners and payers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease | – | –Participants with Crohn's disease. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
| Rheumatoid Arthritis | – | –Participants with rheumatoid arthritis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
| Psoriasis | – | –Participants with psoriasis. All participants will receive at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be males and/or females who are attending a routine clinical visit and meet all of the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of rheumatoid arthritis, Crohn's disease or psoriasis who have made a decision with their physician to commence treatment with adalimumab in accordance with routine medical practice and with the approved adalimumab New Zealand Datasheet.
- Patients who have been evaluated for tuberculosis risk factors/exposure for active/latent tuberculosis infection (per local requirements and according to the approved adalimumab New Zealand Datasheet).
- Adult subjects, 18-75 years old, who have voluntarily signed and dated an informed consent form prior to any study-specific procedures.
Key exclusion criteria (7 listed)
- Previous treatment with adalimumab.
- Previous treatment with any biologic.
- Severe infection including sepsis, active tuberculosis or opportunistic infection.
- Moderate to severe heart failure (New York Heart Association Class II/III).
- Concurrent administration with anakinra.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
Time frame: Baseline, Month 6
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
16 secondary outcomes
Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
Time frame: Baseline, Month 2
Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
Time frame: Baseline, Month 4
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
Time frame: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
Time frame: Baseline, Month 6
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss
Time frame: Baseline, Month 6
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment
Time frame: Baseline, Month 6
Change From Baseline in K10 at Month 6 Across All Indications
Time frame: Baseline, Month 6
Change From Baseline in Flourishing Scale at Month 6 Across All Indications
Time frame: Baseline, Month 6
Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
Time frame: Baseline, Month 6
Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
Time frame: Baseline, Month 6
Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
Time frame: Baseline, Month 6
Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
Time frame: Baseline, Month 6
Number of Participants Remaining on Treatment at Month 6
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31233347Gearry RB, Frampton C, Inns S, Poppelwell D, Rademaker M, Suppiah R. VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand. Curr Med Res Opin. 2019 Oct;35(10):1837-1846. doi: 10.1080/03007995.2019.1634952. Epub 2019 Jul 3.
- http://rxabbvie.com/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Rheumatoid Arthritis, run by AbbVie.
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 3 inclusion and 7 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). 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 WHODAS 2.0 Response Score at Month 6 Across All Indications (time frame: Baseline, Month 6). 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 NCT02451839, 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 19 Jun 2019.