Do cutaneous adverse events significantly affect monoclonal antibody based anti-TNF therapies in inflammatory bowel disease patients? A national experience throughout all care levels through the German Inflammatory Bowel Disease Study Group.

Do cutaneous adverse events significantly affect monoclonal antibody based anti-TNF therapies in inflammatory bowel disease patients? A national experience throughout all care levels through the German Inflammatory Bowel Disease Study Group. - GISG SKIN

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004240

Enrollment

220

Registered

2012-07-09

Start date

2012-12-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50.9 K51.9

Interventions

Group 1: All patients who begin a new anti-TNF therapy for Crohn's disease or ulcerative colitis.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Valid informed consent. Patients who receive a monoclonal anti-TNF agent for Crohn's disease or ulcerative colitis for the first time.

Exclusion criteria

Exclusion criteria: Known skin disorder. Dermatological manifestation of the underlying disease.

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: Impact of a skin reaction during the preceeding month on the anti-TNF therapy in the ongoing month. Primary statistical analysis: comparison of the likelyhood of a therapy modification in a particular month if during the preceeding month (a) no skin reaction occured versus (b) a skin reaction occured	—

Secondary

Measure	Time frame
• How common are skin reactions are anti-TNF related skin reactions in Crohn's disease and ulcerative colitis? • which skin reactions do occur? • When do they occur? • Do skin reactions correlate with the disease phenotype? • Does the inflammatory activity correlate with skin reactions? • Do patient demographics correlate with skin reactions?? • Do skin reactions correlate with concomitant mdeications?	—

Measure

Time frame

• How common are skin reactions are anti-TNF related skin reactions in Crohn's disease and ulcerative colitis? • which skin reactions do occur? • When do they occur? • Do skin reactions correlate with the disease phenotype? • Does the inflammatory activity correlate with skin reactions? • Do patient demographics correlate with skin reactions?? • Do skin reactions correlate with concomitant mdeications?

—

Countries

Germany

Contacts

Public ContactAndrea Steingräber

Charité Campus Virchow-Klinikum

andrea.steingraeber@charite.de(030) 450-553836

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026