Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with Golimumab

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2012-002458-21-NL
• Date of registration: 03/07/2012
• Prospective Registration: Yes
• Primary sponsor: MERCK SHARP & DOHME B.V.
• Public title: Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with Golimumab
• Scientific title: Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab - GO-EASY
• Date of first enrolment: 23/07/2012
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002458-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: Clinical Project Manager
• Affiliation: MERCK SHARP & DOHME B.V.

• Name: Clinical Project Manager
• Affiliation: MERCK SHARP & DOHME B.V.

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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-

Primary Outcome(s)

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.

Main Objective: Determine the difference in the incidence rate of uveitis in subjects with Ankylosing Spondylitis (AS), before and after treatment with 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

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

Secondary Outcome(s)

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

Secondary ID(s)

NL 40935-048-12

MK8259-012-00

Source(s) of Monetary Support

MERCK SHARP & DOHME B.V.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 04/05/2016
• Date Completed: 30/04/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-002458-21/results