Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

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 Criterias

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

Exclusion Criterias

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.

Locations

Dresden, 01067
Cannock, WS11 5XY
Fort Lauderdale, Florida, 33334
Dublin, 4
Hamilton, Ontario, L8N 2B6
...
Dresden, 01067
Cannock, WS11 5XY
Fort Lauderdale, Florida, 33334
Dublin, 4
Hamilton, Ontario, L8N 2B6
Ramat Gan, 5262000
Le Kremlin Bicetre, 94275
Indianapolis, Indiana, 46260
Haifa, 3109601
Smithtown, New York, 11787
Delray Beach, Florida, 33484
Petach Tikva, 4941492
Saint Louis, Missouri, 63141
Indianapolis, Indiana, 46202-5149
Pasadena, California, 91105
Philadelphia, Pennsylvania, 19141
Amsterdam, 1105 AZ
Montpellier, 34295
London, E11 1NR
Leeds, LS7 4SA
Duncansville, Pennsylvania, 16635
Los Angeles, California, 90048
Burlington, Vermont, 05401
Santa Maria, California, 93454
Philadelphia, Pennsylvania, 19152
Manchester, M41 5SL
Berlin, 10117
Cincinnati, Ohio, 45267-0563
Mesa, Arizona, 85208
London, Ontario, N6A 4V2
Dayton, Ohio, 45402
Greenville, North Carolina, 27834
Bruxelles, 1200
Spokane, Washington, 99204
Salt Lake City, Utah, 84132
Danbury, Connecticut, 06810
Shreverport, Louisiana, 71103
Bois Guillaume, 76233
Rochester, New York, 14618
Seattle, Washington, 98104
Haifa, 3339419
Würzburg, 97080
Leipzig, 04103
Bruxelles, 1070
Edmonton, Alberta, T6G 2S2
Chapel Hill, North Carolina, 27599-7600
Drammen, 3004
Houston, Texas, 77074
Ratingen, 40882
Mayfield, Ohio, 44143
Baltimore, Maryland, 21224
Dallas, Texas, 75246
Chicago, Illinois, 60612
Amarillo, Texas, 79124
St Louis, Missouri, 63110
Kalamazoo, Michigan, 49048
Tulsa, Oklahoma, 74135
Tel Aviv, 6423906
Brescia, Lombardia, 25123
Paradise Valley, Arizona, 85253
Calgary, Alberta, T2N 4Z6
Coeur D'alene, Idaho, 83814
Jupiter, Florida, 33458
Madison, Wisconsin, 53792
Boca Raton, Florida, 33486
Albany, New York, 12206
Waco, Texas, 76710
Udine, Friuli-Venezia Giulia, 33100
Cork
Jerusalem, 9112001
Rancho Mirage, California, 92270
Fullerton, California, 92835
Manhasset, New York, 11030
Oslo, 0370
Pisa, Toscana, 56100
Seattle, Washington, 98101
Little Rock, Arkansas, 72205
Toronto, Ontario, M4N 3M5
Boise, Idaho, 83702
Gent, 9000
Newcastle Upon Tyne, NE1 4LP
Orlando, Florida, 32806
Dallas, Texas, 75231
New York, New York, 10003
Paris, 75679
Toulouse, 31059
Lansing, Michigan, 48910
Meridian, Idaho, 83642
Chicago, Illinois, 60637
Boston, Massachusetts, 02215
Oklahoma City, Oklahoma, 73103
Philadelphia, Pennsylvania, 19140
Tromsø, 9038
Tucson, Arizona, 85724
Los Angeles, California, 90045
Rochester, Minnesota, 55905
Oklahoma City, Oklahoma, 73109

Tracking Information

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