Prospective follow-up study of golimumab treatment in ankylosing spondylitis.

Prospective follow-up study of golimumab treatment in ankylosing spondylitis. - Golimumab in Bechterew

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41382

Enrollment

100

Registered

2012-01-05

Start date

2012-03-30

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Ankylosing Spondylitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with ankylosing spondylitis in whom golimumab treatment is started. written informed consent

Exclusion criteria

Exclusion criteria: contraindications against golimumab treatment

Design outcomes

Primary

Measure	Time frame
- ASAS20% response: When there is 20% improvement (and at least 10 points decrease on the 100mm VAS-scales) of at least three out of four domains of the following parameters: inflammation/morning stiffness (BASDAI), function (BASFI), pain (VAS) and patient global assessment (VAS), this therapy will be considered as effective. - ASDAS improvement - BASDAI 50 response	—

Secondary

Measure	Time frame
- the number of adverse events (infections, malignancies, mortality) - improvement of mobility (BASMI) - the peripheral joint swelling (44 joint count) - the ESR and/or CRP - the lipid profile - the production of ANA - relation between genetic polymorphisms and the efficacy of golimumab - radiographic progression (conventional radiography, mSASSscore) - occurrence of extraspinal manifestations (uveitis, colitis, cardiovascular events) - changes in bone mineral density.	—

Measure

Time frame

- the number of adverse events (infections, malignancies, mortality) - improvement of mobility (BASMI) - the peripheral joint swelling (44 joint count) - the ESR and/or CRP - the lipid profile - the production of ANA - relation between genetic polymorphisms and the efficacy of golimumab - radiographic progression (conventional radiography, mSASSscore) - occurrence of extraspinal manifestations (uveitis, colitis, cardiovascular events) - changes in bone mineral density.

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Countries

Netherlands

Outcome results