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An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY) (VITALITY)

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ClinicalTrials.gov Identifier: NCT02451839
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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. 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 (PRO) 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.


Condition or disease
Crohn's Disease Rheumatoid Arthritis Psoriasis

Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : July 6, 2015
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources

Group/Cohort
Crohn's disease
Patients with Crohn's disease
Rheumatoid arthritis
Patients with rheumatoid arthritis
Psoriasis
Patients with psoriasis



Primary Outcome Measures :
  1. Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 response score [ Time Frame: From month 0 to 6 ]
    The WHODAS 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.


Secondary Outcome Measures :
  1. Change in Kessler Psychological Distress Scale (K10) [ Time Frame: From month 0 to 6 ]
    The K10 is intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period.

  2. Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score in patients with Crohn's disease [ Time Frame: From month 0 to 6 ]
    The SIBDQ is a simple, validated, 10 item questionnaire, taken from the original 32 question IBDQ, that can be easily scored and interpreted by clinicians.

  3. Change in Subject Vitality Scale [ Time Frame: From month 0 to 6 ]
    The Subject Vitality Scale evaluates the state of feeling alive and alert -- to having energy available to the self.

  4. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score in patients with rheumatoid arthritis [ Time Frame: From month 0 to 6 ]
    The HAQ-DI was developed as a comprehensive measure of functional status in patients with a wide variety of rheumatic diseases.

  5. Change in Dermatology Life Quality Index (DLQI) score [ Time Frame: From month 0 to 6 ]
    The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.

  6. Change in total WHODAS 2.0 score in adalimumab responder and non-responders population [ Time Frame: From month 0 to 6 ]
    Total WHODAS 2.0 score is assessed at 6 months after the initiation of adalimumab, in those patients continuing on adalimumab (responder population), compared with those patients not continuing on adalimumab (non-responders).

  7. Change in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0 score [ Time Frame: From month 0 to 6 ]
    This questionnaire looks at the effect of health problems on ability to work and perform regular activities

  8. Change in Flourishing Scale [ Time Frame: From month 0 to 6 ]
    The Flourishing Scale consists of 8 items describing important aspects of human functioning ranging from positive relationships, to feelings of competence, to having meaning and purpose in life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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 data sheet.
  • 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).
  • Subject has voluntarily signed and dated an informed consent form prior to any study-specific procedures.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451839


Locations
New Zealand
Waikato Hospital
Hamilton, Waikato, New Zealand, 3204
North Shore Hospital
Auckland, New Zealand, 0622
Auckland City Hospital
Auckland, New Zealand, 1023
Middlemore Clinical Trials
Auckland, New Zealand, 2025
Canterbury District Health Boa
Christchurch, New Zealand, 8011
Memorial Avenue Consultancy
Christchurch, New Zealand, 8053
Dunedin Hospital
Dunedin, New Zealand, 9016
Hawke's Bay Hospital
Hawke's BAY, New Zealand
Hutt Hospital
Lower Hutt, New Zealand, 5010
Porter Rheumatology Ltd
Nelson, New Zealand, 7010
Waitemata Distric Health Board
North Shore, New Zealand
Tauranga Hospital
Tauranga, BAY OF Plenty, New Zealand, 3143
Timaru Hospital
Timaru, New Zealand
Wellington Hospital
Wellington, New Zealand, 6021
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02451839     History of Changes
Other Study ID Numbers: P15-345
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Crohn Disease
Arthritis, Rheumatoid
Psoriasis
Patient Outcome Assessment
Adalimumab
Global Health
Quality of Life

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Psoriasis
Crohn Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents