Recruitment

Recruitment Status
Completed

Inclusion Criteria

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;
eligible for re-treatment, based on clinical symptoms;
adult patients 18-80 years of age with active RA;
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;
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
development of any new contraindications to receiving MabThera;
...
patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.

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

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;
eligible for re-treatment, based on clinical symptoms;
adult patients 18-80 years of age with active RA;
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;
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
development of any new contraindications to receiving MabThera;
...
patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
development of any new contraindications to receiving MabThera;
women who are pregnant or breast-feeding.

Tracking Information

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