Recruitment

Recruitment Status
Completed

Inclusion Criteria

eligible for re-treatment, based on clinical symptoms;
adult patients 18-80 years of age with active RA;
patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
...
eligible for re-treatment, based on clinical symptoms;
adult patients 18-80 years of age with active RA;
patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
patients of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria

patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.
...
patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Inclusion Criteria

eligible for re-treatment, based on clinical symptoms;
adult patients 18-80 years of age with active RA;
patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
...
eligible for re-treatment, based on clinical symptoms;
adult patients 18-80 years of age with active RA;
patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
patients of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria

patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.
...
patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;

Tracking Information

NCT #
NCT02097745
Collaborators
Biogen
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche