Ankylosing Spondylitis (Bechterew disease) MedDRA version: 14.1 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Simponi
Pharmaceutical Form: Injection
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
MERCK SHARP & DOHME B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject should not have received golimumab before the study. 2. Each subject is prescribed golimumab according to routine daily practice. 3.Each subject must be able to provide retrospective data concerning EAM episodes with a recall period of at least 12 months prior to anti-TNF use. 4. Each subject must be willing and able to provide written informed consent for the study. The legal representative (e.g. parent or guardian) for a subject unable to provide independent consent may provide written informed consent for the subject. 5. Each subject must be = 18 years of age. A subject may be of either sex, any race/ethnicity. 6. Each subject must have definite AS according to the modified New York criteria in the Netherlands. 7. Each subject must be candidate for treatment with anti-TNF according to the ASAS consensus. 8. Each subject must be able to adhere to dose and visit schedules. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Any exclusion criterion as stated in the SPC for golimumab 2. The subject has used any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the difference in the incidence rate of uveitis in subjects with Ankylosing Spondylitis (AS), before and after treatment with golimumab;Secondary Objective: - Determine the difference in the incidence rate of new onsets or flares of IBD and psoriasis in AS patients before treatment and after the start of golimumab - Determine the effectiveness of golimumab on AS disease activity, as assessed by BASDAI 50% and ASDAS in routine daily practice.;Primary end point(s): is to determine the difference in the annual incidence rate of uveitis attacks in AS patients before treatment and after the start of golimumab;Timepoint(s) of evaluation of this end point: Day -14 through -1 Day 1 Day 28 Month 3 Month 6 Month 9 Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Determine the difference in the incidence rate of new onsets or flares of IBD and psoriasis in AS patients before treatment and after the start of golimumab - Determine the effectiveness of golimumab on AS disease activity, as assessed by BASDAI 50% and ASDAS in routine daily practice.;Timepoint(s) of evaluation of this end point: Day -14 through -1 Day 1 Day 28 Month 3 Month 6 Month 9 Month 12 | — |
Countries
Netherlands
Contacts
Public ContactClinical Project Manager
MERCK SHARP & DOHME B.V.
Outcome results
None listed