A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis

A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis - An RCT of golimumab+MTX vs MTX alone in MTX-naive PsA

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44820

Enrollment

Registered

2013-06-12

Start date

2013-08-23

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

psoriatic arthritis spondylartropathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Psoriatic arthritis according to the CASPAR classification Active disease, with a minimal of 3 swollen and tender joints 18-70 years

Exclusion criteria

Exclusion criteria: Methotrexate naive TNF blocker naive Concurrent and previous DMARD use Malignancy

Design outcomes

Primary

Measure	Time frame
- Safety up till week 22 - DAS remission up till week 22	—

Secondary

Measure	Time frame
- EULAR DAS response at week 22 - ACR20, ACR50 and ACR70 at week 22 - PsARC at week 22 - PASI75 at week 22 - Leeds Enthesitis Index (LEI) at week 22 - Dactylitis at week 22 - Changes in HAQ between baseline and week 22 - % of patients achieving low disease activity (defined as DAS	—

Countries

Netherlands

Outcome results