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

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005214-19-NL

Enrollment

Registered

2013-06-20

Start date

2013-06-20

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

active psoriatic arthritis

Interventions

Trade Name: Simponi Product Name: Golimumab Pharmaceutical Form: Solution for infusion in pre-filled syringe Pharmaceutical form of the placebo: Solutio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Psoriatic arthritis according to the CASPAR classification - Active disease, minimally 3 swollen and tender joints - 18-70 years - a stable dose of concomitant NSAIDs and/or corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent = 10 mg/day and must be stable for at least 4 weeks prior to baseline. - Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and electrocardiography (ECG). 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Methotrexate naive TNF blocker naive Concurrent DMARD use Malignancy <5 years ago no active children wish, pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in methotrexaat naïve PsA patients ; Primary end point(s): - Safety - DAS remission ;Timepoint(s) of evaluation of this end point: week 22; Secondary Objective: - to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in MTX naïve PsA patients - to demonstrate that initial treatment of MTX naïve patients with golimumab + MTX is superior to MTX alone to maintain low to very low disease activity over time after withdrawing golimumab treatment	—

Measure

Time frame

Main Objective: to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in methotrexaat naïve PsA patients ; Primary end point(s): - Safety - DAS remission ;Timepoint(s) of evaluation of this end point: week 22; Secondary Objective: - to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in MTX naïve PsA patients - to demonstrate that initial treatment of MTX naïve patients with golimumab + MTX is superior to MTX alone to maintain low to very low disease activity over time after withdrawing golimumab treatment

—

Secondary

Measure	Time frame
Secondary end point(s): - EULAR DAS response - ACR20, ACR50 and ACR70 - PsARC - PASI75 - Leeds Enthesitis Index (LEI) - Dactylitis - Changes in HAQ - % of patients achieving low disease activity (defined as DAS <2.4) - % of patients achieving minimal disease activity (as defined by Coates et al, Ann Rheum Dis 2010) Exploratory: - Safety - EULAR response, ACR20/50/70 and PsARC - Survival analysis of patients remaining in DAS remission - Survival analysis of patients retaining low disease activity (defined as DAS <2.4) - Survival analysis of patients retaining minimal disease activity (as defined by Coates et al, Ann Rheum Dis 2010) ;Timepoint(s) of evaluation of this end point: week 50	—

Measure

Time frame

Secondary end point(s): - EULAR DAS response - ACR20, ACR50 and ACR70 - PsARC - PASI75 - Leeds Enthesitis Index (LEI) - Dactylitis - Changes in HAQ - % of patients achieving low disease activity (defined as DAS <2.4) - % of patients achieving minimal disease activity (as defined by Coates et al, Ann Rheum Dis 2010) Exploratory: - Safety - EULAR response, ACR20/50/70 and PsARC - Survival analysis of patients remaining in DAS remission - Survival analysis of patients retaining low disease activity (defined as DAS <2.4) - Survival analysis of patients retaining minimal disease activity (as defined by Coates et al, Ann Rheum Dis 2010) ;Timepoint(s) of evaluation of this end point: week 50

—

Countries

Netherlands

Contacts

Public ContactDominique Baeten

Academic Medical Center, Department of Rheumatology

d.l.baeten@amc.uva.nl+31205667765

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026