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Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction

NCT01491815 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 812

Last updated 2022-07-08

No results posted yet for this study

Summary

This is an international (Sweden, Finland, Norway, Denmark, Iceland and the Netherlands) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare

1. the proportion of subjects who achieve remission with ACT versus three different biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab)
2. two alternative de-escalation strategies in patients who respond to first-line therapy.

Conditions

Interventions

DRUG

Non-biological DMARD's

Methotrexate: 25mg/week. SSZ: 2 g/day. HCQ: 35 mg/kg/week (Finland and Denmark) Methotrexate: 25mg/week. Prednisolone 20 mg/day tapered in 9 weeks to 5 mg/day, discontinued after 9 months. (Sweden, Norway, Iceland, and the Netherlands)

BIOLOGICAL

Cimzia

Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week

BIOLOGICAL

Orencia

Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week

BIOLOGICAL

RoActemra

Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week

Sponsors & Collaborators

Principal Investigators

  • Ronald van Vollenhoven, MD, Prof. · The Karolinska Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-14
Primary Completion
2023-07-31
Completion
2023-12-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491815 on ClinicalTrials.gov