NCT02322008

Brief Summary

Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,035

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

December 17, 2014

Last Update Submit

December 22, 2014

Conditions

Crohn's DiseaseUlcerative ColitisInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 3-step scale

    Best response within 22 weeks

    22 weeks

Interventions

infliximab and adalimumabBIOLOGICAL

In this retrospective, observational study, no interventions were undertaken by the researchers.

Also known as: remicade and humira, anti-TNF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1035 patients with CD or UC

You may qualify if:

  • CD or UC, treated with anti-TNF

You may not qualify if:

  • Missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bank S, Andersen PS, Burisch J, Pedersen N, Roug S, Galsgaard J, Turino SY, Brodersen JB, Rashid S, Avlund S, Olesen TB, Green A, Hoffmann HJ, Thomsen MK, Thomsen VO, Nexo BA, Vogel U, Andersen V. Effectiveness of anti-tumour necrosis factor-alpha therapy in Danish patients with inflammatory bowel diseases. Dan Med J. 2015 Mar;62(3):A4994.

    PMID: 25748864DERIVED

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Interventions

InfliximabAdalimumab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Humanized

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.sc, phd

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

September 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 23, 2014

Record last verified: 2014-12