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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02451839
First received: May 20, 2015
Last updated: January 20, 2017
Last verified: January 2017
  Purpose

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
Crohn's Disease
Rheumatoid Arthritis
Psoriasis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 190
Study Start Date: July 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Crohn's disease
Patients with Crohn's disease
Rheumatoid arthritis
Patients with rheumatoid arthritis
Psoriasis
Patients with psoriasis

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02451839

Contacts
Contact: David G Poppelwell, BS +64 29 201 4709 david.poppelwell@abbvie.com
Contact: Alan D Watts, PhD +61 412 201 413 alan.watts@abbvie.com

Locations
New Zealand
Site Reference ID/Investigator# 139035 Not yet recruiting
Auckland, New Zealand, 0620
Principal Investigator: Site Reference ID/Investigator# 139035, MD         
Site Reference ID/Investigator# 141720 Recruiting
Auckland, New Zealand, 0740
Principal Investigator: Site Reference ID/Investigator# 141720, MD         
Site Reference ID/Investigator# 139350 Recruiting
Auckland, New Zealand, 1023
Principal Investigator: Site Reference ID/Investigator# 139350, MD         
Site Reference ID/Investigator# 139351 Recruiting
Auckland, New Zealand, 1023
Principal Investigator: Site Reference ID/Investigator# 139351, MD         
Site Reference ID/Investigator# 141687 Recruiting
Auckland, New Zealand, 1640
Principal Investigator: Site Reference ID/Investigator# 141687, MD         
Site Reference ID/Investigator# 139027 Recruiting
Christchurch, Canterbury, New Zealand, 8140
Principal Investigator: Site Reference ID/Investigator# 139027, MD         
Site Reference ID/Investigator# 139036 Recruiting
Christchurch, Canterbury, New Zealand, 8140
Principal Investigator: Site Reference ID/Investigator# 139036, MD         
Site Reference ID/Investigator# 146019 Recruiting
Christchurch, New Zealand, 8053
Principal Investigator: Site Reference ID/Investigator# 146019, MD         
Site Reference ID/Investigator# 139032 Recruiting
Dunedin, Otago, New Zealand, 9054
Principal Investigator: Site Reference ID/Investigator# 139032, MD         
Site Reference ID/Investigator# 139033 Recruiting
Dunedin, Otago, New Zealand, 9054
Principal Investigator: Site Reference ID/Investigator# 139033, MD         
Site Reference ID/Investigator# 139352 Recruiting
Hamilton, Waikato, New Zealand, 3204
Principal Investigator: Site Reference ID/Investigator# 139352, MD         
Site Reference ID/Investigator# 139029 Recruiting
Hamilton, New Zealand, 3204
Principal Investigator: Site Reference ID/Investigator# 139029, MD         
Site Reference ID/Investigator# 139030 Recruiting
Hamilton, New Zealand, 3204
Principal Investigator: Site Reference ID/Investigator# 139030, MD         
Site Reference ID/Investigator# 139353 Recruiting
Hawke's Bay, New Zealand
Principal Investigator: Site Reference ID/Investigator# 139353, MD         
Site Reference ID/Investigator# 139354 Recruiting
Hawke's Bay, New Zealand
Principal Investigator: Site Reference ID/Investigator# 139354, MD         
Site Reference ID/Investigator# 139383 Recruiting
Nelson, New Zealand, 7010
Principal Investigator: Site Reference ID/Investigator# 139383, MD         
Site Reference ID/Investigator# 141688 Recruiting
North Shore, New Zealand
Principal Investigator: Site Reference ID/Investigator# 141688, MD         
Site Reference ID/Investigator# 139360 Recruiting
Tauranga, Bay of Plenty, New Zealand, 3143
Principal Investigator: Site Reference ID/Investigator# 139360, MD         
Site Reference ID/Investigator# 139381 Recruiting
Tauranga, Bay of Plenty, New Zealand, 3143
Principal Investigator: Site Reference ID/Investigator# 139381, MD         
Site Reference ID/Investigator# 139034 Recruiting
Timaru, New Zealand, 7940
Principal Investigator: Site Reference ID/Investigator# 139034, MD         
Site Reference ID/Investigator# 139355 Recruiting
Wellington, New Zealand, 6021
Principal Investigator: Site Reference ID/Investigator# 139355, MD         
Site Reference ID/Investigator# 141721 Recruiting
Wellington, New Zealand, 6021
Principal Investigator: Site Reference ID/Investigator# 141721, MD         
Site Reference ID/Investigator# 139031 Recruiting
Wellington, New Zealand
Principal Investigator: Site Reference ID/Investigator# 139031, MD         
Site Reference ID/Investigator# 139356 Recruiting
Wellington, New Zealand
Principal Investigator: Site Reference ID/Investigator# 139356, MD         
Sponsors and Collaborators
AbbVie
Investigators
Principal Investigator: Richard Gearry, MD University of Otago, Christchurch, Christchurch, NEW ZEALAND
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02451839     History of Changes
Other Study ID Numbers: P15-345
Study First Received: May 20, 2015
Last Updated: January 20, 2017

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

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

ClinicalTrials.gov processed this record on March 24, 2017