An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice
ACT SOLO
Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO
1 other identifier
observational
608
1 country
119
Brief Summary
This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Typical duration for all trials
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
October 28, 2016
CompletedOctober 28, 2016
September 1, 2016
2.7 years
November 15, 2011
September 8, 2016
September 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion
The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.
Day 1
Secondary Outcomes (21)
Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)
Day 1 (assessment of discontinuations within prior 2 years)
Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide
Day 1 (assessment of discontinuations within prior 2 years)
Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine
Day 1 (assessment of discontinuations within prior 2 years)
Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine
Day 1 (assessment of discontinuations within prior 2 years)
Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)
Day 1 (assessment of discontinuations within prior 2 years)
- +16 more secondary outcomes
Study Arms (1)
Tocilizumab
Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
Interventions
Tocilizumab administered according to prescribing information and normal clinical practice.
Eligibility Criteria
Moderate to severe rheumatoid arthritis participants treated with tocilizumab in routine clinical practice
You may qualify if:
- Adult participants, \>/= 18 years of age
- Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy
You may not qualify if:
- Current participation in a clinical trial in rheumatoid arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (119)
Unknown Facility
Aix-les-Bains, 73106, France
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Amiens, 80000, France
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Amiens, 80054, France
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Angers, 49933, France
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Auch, 32008, France
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Aulnay-sous-Bois, 93602, France
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Avignon, 84902, France
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Bastia, 20604, France
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Bayonne, 64109, France
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Beauvais, 60021, France
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Belfort, 90016, France
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Belley, 01306, France
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Berck, 62608, France
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Besançon, 25030, France
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Bobigny, 93009, France
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Bois-Guillaume, 76233, France
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Bondy, 93143, France
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Bonneville, 74136, France
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Bordeaux, 33075, France
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Bordeaux, 33076, France
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Boulogne-Billancourt, 92104, France
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Bressuire, 79302, France
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Brest, 29609, France
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Bry-sur-Marne, 94366, France
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Caen, 14033, France
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Cahors, 46005, France
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Cannes, 06401, France
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Carcassonne, 11890, France
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Chambray-lès-Tours, 37170, France
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Chambray-lès-Tours, 37171, France
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Châteauroux, 36019, France
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Clermont-Ferrand, 63003, France
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Colmar, 68024, France
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Compiègne, 60321, France
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Corbeil-essones, 91106, France
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Corbeil-Essonnes, 91106, France
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Créteil, 94010, France
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Denain, 59723, France
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Digne-les-Bains, 04000, France
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Dijon, 21000, France
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Dole, 39108, France
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Draguignan, 83300, France
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Druex, 28102, France
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Échirolles, 38434, France
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Épernay, 51200, France
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Évian-les-Bains, 74500, France
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Évreux, 27015, France
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Évry, 91024, France
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Freyming-Merlebach, 57804, France
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Fréjus, 83608, France
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Gap, 05000, France
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Gleizé, 69400, France
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Haguenau, 67500, France
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Ivry-sur-Seine, 94200, France
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Laon, 02001, France
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Lavaur, 81500, France
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Le Bouscat, 33491, France
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Le Coudray, 28630, France
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Le Kremlin-Bicêtre, 94275, France
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Libourne, 33505, France
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Liévin, 62806, France
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Lille, 59037, France
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Limoges, 87042, France
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Limoges, 87100, France
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Lomme, 59462, France
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Lyon, 69002, France
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Lyon, 69437, France
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Maisons-Laffitte, 78600, France
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Marseille, 13006, France
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Marseille, 13274, France
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Marseille, 13384, France
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Metz-Tessy, 74370, France
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Montauban, 82017, France
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Montpellier, 34295, France
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Moulins, 03000, France
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Mulhouse, 68070, France
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Nanterre, 92014, France
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Nantes, 44035, France
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Narbonne, 11108, France
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Nevers, 58000, France
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Nice, 06202, France
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Nîmes, 30029, France
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Orange, 84106, France
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Paris, 75475, France
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Paris, 75571, France
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Paris, 75651, France
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Paris, 75679, France
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Paris, 75877, France
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Paris, 75960, France
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Perpignan, 66046, France
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Périgueux, 24019, France
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Pierre-Bénite, 69495, France
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Poissy, 78303, France
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Pontoise, 95300, France
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Reims, 51092, France
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Rennes, 35203, France
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Rodez, 12027, France
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Roubaix, 59056, France
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Saint-Brieuc, 22027, France
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Saint-Chamond, 42403, France
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Saint-Mandé, 94163, France
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Saint-Priest-en-Jarez, 42277, France
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Salon-de-Provence, 13658, France
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Ste Maxime, 83120, France
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Strasbourg, 67098, France
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Suresnes, 92151, France
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Thionville, 57126, France
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Toulon, 83041, France
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Toulouse, 31059, France
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Toulouse, 31076, France
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Toulouse, 31077, France
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Tourcoing, 59208, France
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Valenciennes, 59300, France
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Valenciennes, 59322, France
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Vandœuvre-lès-Nancy, 54511, France
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Vannes, 56017, France
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Villeneuve-Saint-Georges, 94195, France
Unknown Facility
Villeurbanne, 69626, France
Unknown Facility
Vlleneuve Sur Lot, 47307, France
Related Publications (1)
Flipo RM, Maillefert JF, Chazerain P, Idier I, Coudert M, Tebib J. Factors influencing the use of tocilizumab as monotherapy in patients with rheumatoid arthritis in a real-life setting: results at 1 year of the ACT-SOLO study. RMD Open. 2017 Jan 10;3(1):e000340. doi: 10.1136/rmdopen-2016-000340. eCollection 2017.
PMID: 28123778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2011
First Posted
November 18, 2011
Study Start
January 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 28, 2016
Results First Posted
October 28, 2016
Record last verified: 2016-09