A controlled in vitro hypersensitivity assessment in subjects previously treated whit the combination of GLPG3067 and GLPG2222, or the combination of GLPG3067, GLPG222 and GLPG2737 using Lymphocyte Transformation Test.

A controlled in vitro hypersensitivity assessment in subjects previously treated whit the combination of GLPG3067 and GLPG2222, or the combination of GLPG3067, GLPG222 and GLPG2737 using Lymphocyte Transformation Test. - Study to investigate hypersensitivity with a LTT test.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45940

Enrollment

Registered

2018-06-25

Start date

2018-06-11

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Skin reaction (e.g. rash)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - trial subjects: subjects who participated in Part 4 or Part 5 of the GLPG3067 -CL -101 or the GLPG3067-CL-108 clinical trial and developed skin reactions suspected as drug hypersensitivity, OR -control subjects: subjects who participated in Part 4 or Part 5 of the GLPG3067- CL- 101 or the GLPG3067-CL-108 clinical trial and did not develop any skin reaction or drug hypersensitivity signs.;- Able and willing to comply with the protocol requirements and to sign the ICF as approved by the Independent Ethics Committee (IEC), before any study-related procedures are performed.

Exclusion criteria

Exclusion criteria: - Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

Design outcomes

Primary

Measure	Time frame
For this follow-up study, blood will be collected and this blood will be used for a so called lymphocyte transformation test (LTT). The LTT is a useful test for the diagnosis of drug hypersensitivity. The LTT will be done in order to better understand the cause of these hypersensitivity skin reactions.	—

Countries

Netherlands

Outcome results