Trials / Completed
CompletedNCT02750800
Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 427 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical setting in Hungary.
Detailed description
This was a prospective, open label, multicenter, observational cohort study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. AbbVie offered an array of services as part of a patient support program, called AbbVie Care 2.0, to study participants. The purpose of the AbbVie Care 2.0 program was to provide educational resources that aimed to help participants understand their health condition and disease management (e.g., lifestyle - exercise or diet), but also help to them understand how to administer the product safely and be empowered to stay on track with their prescribed treatment plan, all with the goal of maximizing patient outcomes. There were five target visits: a baseline visit at enrollment and follow-up visits at 3, 6, 9 and 12 months.
Conditions
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Psoriatic Arthritis
- Psoriasis
- Crohn's Disease
- Ulcerative Colitis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adalimumab | Pre-filled syringe or pen, administered by subcutaneous injection |
| BEHAVIORAL | AbbVie Care 2.0 | Supportive services provided to participants included reminder calls, emails, text messages, nursing services, dietician, and psychological support. An adalimumab starter pack, injection guide, digital and print educational materials were also provided. |
Timeline
- Start date
- 2016-04-07
- Primary completion
- 2018-04-03
- Completion
- 2018-04-03
- First posted
- 2016-04-26
- Last updated
- 2019-11-06
- Results posted
- 2019-11-06
Source: ClinicalTrials.gov record NCT02750800. Inclusion in this directory is not an endorsement.