Drug Safety on Biological-therapy through clinical Pharmaceutical care on Inflammatory Bowel Disease. A Prospective Study to determine the influence of Pharmaceutical care on patients Knowledge, drug safety and Quality of Life.

Drug Safety on Biological-therapy through clinical Pharmaceutical care on Inflammatory Bowel Disease. A Prospective Study to determine the influence of Pharmaceutical care on patients Knowledge, drug safety and Quality of Life. - AdPhaNCED

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020374

Enrollment

120

Registered

2020-01-08

Start date

2019-07-08

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: Intervention Group( On top of the Standard of care: Pharmaceutical care to avoid adverse Events) Group 2: Control Group (Standard of care)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: IBD Patients, receiving a biological therapy at the Medizinische Klinik 1 - Hochschulambulanz Erlangen At least 3 months of biological therapy clinical Remission or mild disease (Partial Mayo Score = 6 or HBI = 8) female or male Age: at least 18 years old Fill in questionnaire

Exclusion criteria

Exclusion criteria: Missing German language skills cognitive limitations Patients which won't accept the Trial oral Glucocorticoid therapy for active disease Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Reduction of adverse events after 12 months of biological therapy Improvement of health related quality of life after 12 months	—

Secondary

Measure	Time frame
Improvement of fatigue after 12 months Improvement of medical knowledge (biological) after 12 months Unsolved medication errors after 12 months	—

Countries

Germany

Contacts

Public ContactJohannes Plechschmidt

Apotheke des Universitätsklinikums Erlangen

johannes.plechschmidt@uk-erlangen.de09131-8533592

Outcome results

None listed

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