A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) (GO-NICE)
Status
Completed
Conditions
Spondylitis, Ankylosing
Arthritis, Psoriatic
Arthritis, Rheumatoid
Treatments
Drug: Methotrexate
Drug: Simponi®
Study type
Observational
Funder types
Industry
Identifiers
Details and patient eligibility
About
This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.
Enrollment
1,613 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time
Exclusion criteria
- No specific exclusion criteria
Trial design
1,613 participants in 3 patient groups
Participants with Rheumatoid Arthritis
Description:
Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
Treatment:
Drug: Simponi®
Drug: Methotrexate
Participants with Psoriatic Arthritis
Description:
Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
Treatment:
Drug: Simponi®
Participants with Ankylosing Spondylitis
Description:
Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Treatment:
Drug: Simponi®
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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