Golimumab efficacy in psoriatic arthritis patients with active dactylitis

A multicentre, randomized, double-blind, parallel–group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy, in improving dactylitis and enthesitis, in MTX naïve psoriatic arthritis patients - GO-DACT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000643-40-PT

Enrollment

136

Registered

2013-09-24

Start date

2014-01-10

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Psoriatic arthritis MedDRA version: 18.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Trade Name: Simponi Product Name: golimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: GOLIMUMAB CAS Number: 47618

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than18 years, with the diagnosis of PsA according to CASPAR criteria, established at least 3 months prior to screening, with tender dactylitis, refractory to at least two systemic NSAIDs, at optimal dosage, for 3 months. 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: Exclusion criteria are those considered for any antiTNF agent and MTX or that might interfere with trial evaluations or patient’s safety.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate differences of efficacy of golimumab in combination MTX in comparison with MTX monotherapy, in improving dactylitis at 24 weeks versus baseline, in MTX naive PsA patients.; Secondary Objective: To assess the efficacy of golimumab in combination with MTX versus MTX monotherapy on: • enthesitis • feet and hands inflammation assessed by MRI • peripheral and axial joint involvement • skin and nail involvement • function • composite indexes of disease activity • quality of life To assess the safety of golimumab in combination with MTX versus MTX monotherapy on: • serious and non-serious adverse events • immunogenicity of golimumab in association with MTX ;Primary end point(s): -Changes from baseline of the Dactylitis Severity Score (DSS) at 24 weeks.;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: To demonstrate differences of efficacy of golimumab in combination MTX in comparison with MTX monotherapy, in improving dactylitis at 24 weeks versus baseline, in MTX naive PsA patients.; Secondary Objective: To assess the efficacy of golimumab in combination with MTX versus MTX monotherapy on: • enthesitis • feet and hands inflammation assessed by MRI • peripheral and axial joint involvement • skin and nail involvement • function • composite indexes of disease activity • quality of life To assess the safety of golimumab in combination with MTX versus MTX monotherapy on: • serious and non-serious adverse events • immunogenicity of golimumab in association with MTX ;Primary end point(s): -Changes from baseline of the Dactylitis Severity Score (DSS) at 24 weeks.;Timepoint(s) of evaluation of this end point: 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - Changes from baseline of the dactylits severity score (DSS) at 12 weeks. - Changes from baseline of the Leeds Dactylitis Score (LDI) at 12 and 24 weeks. - Proportion of patients achieving DSS20, DSS50 and DSS70 at 12 and 24 weeks. - Proportion of patients achieving LDI20, LDI50 and LDI70 at 12 and 24 weeks. - Proportion of patient achieving dactylitis remission at 12 and 24 weeks in comparison with baseline - Proportion of patients with tender and non tender dactylitis at 12 and 24 weeks in comparison with baseline - Changes from baseline of the LEI and SPARCC scores at 12 and 24 weeks. - Proportion of patients achieving enthesitis remission, at 12 and 24 weeks comparing with baseline - Changes from baseline in psoriatic arthritis MRI scoring system for the wrists and hands (PSAMRIS-H) and for feet and ankle (PSAMRIS-F) at week 24. - Changes from baseline of dactylitis MRI score at week 24. - Changes from baseline in 68 tender and 66 swollen joint counts at 12 and 24 weeks. - Changes from baseline of patient and physician disease activity assessment using visual analogical scales at 12 and 24 weeks. - Changes from baseline of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) at 12 and 24 weeks, in patients with axial involvement. - Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50, 75 and 90 response at 12 and 24 weeks. - Changes from baseline in target Nail Psoriasis Severity Index (target NAPSI) score, at week 12 and 24. - Changes from baseline in functional indexes Health Assessment Questionnaire Disability Index (HAQ) and Bath Ankylosing Spondylitis Functional Index (BASFI) at 12 and 24 weeks.	—

Measure

Time frame

Secondary end point(s): - Changes from baseline of the dactylits severity score (DSS) at 12 weeks. - Changes from baseline of the Leeds Dactylitis Score (LDI) at 12 and 24 weeks. - Proportion of patients achieving DSS20, DSS50 and DSS70 at 12 and 24 weeks. - Proportion of patients achieving LDI20, LDI50 and LDI70 at 12 and 24 weeks. - Proportion of patient achieving dactylitis remission at 12 and 24 weeks in comparison with baseline - Proportion of patients with tender and non tender dactylitis at 12 and 24 weeks in comparison with baseline - Changes from baseline of the LEI and SPARCC scores at 12 and 24 weeks. - Proportion of patients achieving enthesitis remission, at 12 and 24 weeks comparing with baseline - Changes from baseline in psoriatic arthritis MRI scoring system for the wrists and hands (PSAMRIS-H) and for feet and ankle (PSAMRIS-F) at week 24. - Changes from baseline of dactylitis MRI score at week 24. - Changes from baseline in 68 tender and 66 swollen joint counts at 12 and 24 weeks. - Changes from baseline of patient and physician disease activity assessment using visual analogical scales at 12 and 24 weeks. - Changes from baseline of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) at 12 and 24 weeks, in patients with axial involvement. - Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50, 75 and 90 response at 12 and 24 weeks. - Changes from baseline in target Nail Psoriasis Severity Index (target NAPSI) score, at week 12 and 24. - Changes from baseline in functional indexes Health Assessment Questionnaire Disability Index (HAQ) and Bath Ankylosing Spondylitis Functional Index (BASFI) at 12 and 24 weeks.

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Countries

Portugal

Contacts

Public ContactUnidade Investigação Reumatologia

Instituto de Medicina Molecular

elsa-sousa@hotmail.com+35121 7999544

Outcome results

None listed

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