The impact of biological interventions on health‐related quality of life in adults with Crohn's disease 

Lead Investigator: Mirjana Stanic Benic, UHC Rijeka
Title of Proposal Research: The impact of biological interventions on health‐related quality of life in adults with Crohn’s disease
Vivli Data Request: 3270
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research: 

Health related quality of life (HRQoL) represents a functional effect of the disease and it is one of the main issues in people with Crohn disease (CD). Modifying the disease course, the biological treatment may have a substantial effect on HRQoL and therefore would be beneficial to be introduced earlier in the treatment with regard to HRQoL outcomes (Bodger 2002). Studies increasingly include HRQoL as a secondary outcome and no systematic review has clearly established the evidence for an improvement in HRQoL in this population. A previous literature review on the impact of biologics on HRQoL in inflammatory bowel disease (IBD) patients has been limited in the scope and time of the articles retrieved (IBD population, including both CD and ulcerative colitis) and methodological concept (articles only in English, only inflammatory bowel disease questionairre (IBDQ) and 36-Item Short Form Survey (SF‐36) as outcome measures) (Vogelaar 2009). This review endeavours to address an up‐to‐date critical view growing evidence on the impact of biological interventions in improving HRQoL in people with CD. 

Requested Studies:
A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn’s Disease 

Sponsor: AbbVie
Study ID:  NCT00077779
Sponsor ID: M02-404 

A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn’s Disease 

Sponsor: AbbVie
Study ID: NCT00055523
Sponsor ID: M02-403 

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn’s Disease 

Sponsor: AbbVie
Study ID: NCT00055497 
Sponsor ID: M02-433 

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn’s Disease Who Have Lost Response or Are Intolerant to Infliximab 

Sponsor: AbbVie
Study ID:  NCT00105300
Sponsor ID: M04–691 

A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn’s Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission 

Sponsor: Biogen
Study ID:  NCT00055536
Sponsor ID: CD306 

A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn’s Disease 

Sponsor: Biogen
Study ID:  NCT00032799
Sponsor ID: CD301 

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn’s Disease With Elevated C-Reactive Protein 

Sponsor: Biogen
Study ID:  NCT00078611
Sponsor ID: ELN100226-CD307