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

NCT02451839 | Completed Results

• 1 other identifier: P15-345
• Study Type: observational
• Target: 168
• Locations: 0 countries
• Sites: N/A

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 (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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 6

Secondary Outcomes (16)

• Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications

  Baseline, Month 2

• Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications

  Baseline, Month 4

• Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease

  Baseline, Month 6

• Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis

  Baseline, Month 6

• Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis

  Baseline, Month 6

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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.

  PMID: 31233347 DERIVED

Related Links

• http://rxabbvie.com/

MeSH Terms

Conditions

Crohn Disease; Arthritis, Rheumatoid; Psoriasis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 22, 2015
• Study Start: July 6, 2015
• Primary Completion: December 5, 2017
• Study Completion: December 5, 2017
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2018-01