Clinical trial NCT01474291: An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice
Official title: Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moderate to severe rheumatoid arthritis participants treated with tocilizumab in routine clinical practice

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Current participation in a clinical trial in rheumatoid arthritis

Primary outcomes:
measure: Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)
timeFrame: Day 1 (assessment of discontinuations within prior 2 years)
measure: Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide
timeFrame: Day 1 (assessment of discontinuations within prior 2 years)
measure: Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine
timeFrame: Day 1 (assessment of discontinuations within prior 2 years)
measure: Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine
timeFrame: Day 1 (assessment of discontinuations within prior 2 years)
measure: Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)
timeFrame: Day 1 (assessment of discontinuations within prior 2 years)
measure: Mean Number of Tocilizumab Infusions Over the Study Period
timeFrame: Up to 30 months
measure: Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period
timeFrame: Up to 13.4 months
measure: Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period
timeFrame: Up to 30 months
measure: Percentage of Participants With at Least One csDMARD Intensification During the Study
timeFrame: Up to 30 months
measure: Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12
timeFrame: Month 12
measure: Percentage of Participants With DAS28-ESR Remission at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12
timeFrame: Month 12
measure: Percentage of Participants With CDAI Remission at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12
timeFrame: Month 12
measure: Percentage of Participants With SDAI Remission at Month 12
timeFrame: Month 12
measure: Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12
timeFrame: Month 12
measure: Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
timeFrame: Baseline; Month 6; Month 12
measure: Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
timeFrame: Baseline; Month 6, Month 12
measure: Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.
timeFrame: Baseline; Month 6; Month 12
measure: Percentage of Participants With Adverse Events
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Aix Les Bains
country: France
city: Amiens
country: France
city: Amiens
country: France
city: Angers
country: France
city: Auch
country: France
city: Aulnay Sous Bois
country: France
city: Avignon
country: France
city: Bastia
country: France
city: Bayonne
country: France
city: Beauvais
country: France
city: Belfort
country: France
city: Belley
country: France
city: Berck
country: France
city: Besancon
country: France
city: Bobigny
country: France
city: Bois Guillaume
country: France
city: Bondy
country: France
city: Bonneville
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne-billancourt
country: France
city: Bressuire
country: France
city: Brest
country: France
city: Bry Sur Marne
country: France
city: Caen
country: France
city: Cahors
country: France
city: Cannes
country: France
city: Carcassonne
country: France
city: Chambray Les Tours
country: France
city: Chambray Les Tours
country: France
city: Chateauroux
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Corbeil Essonnes
country: France
city: Corbeil-essones
country: France
city: Creteil
country: France
city: Denain
country: France
city: Digne Les Bains
country: France
city: Dijon
country: France
city: Dole
country: France
city: Draguignan
country: France
city: Druex
country: France
city: Echirolles
country: France
city: Epernay
country: France
city: Evian Les Bains
country: France
city: Evreux
country: France
city: Evry
country: France
city: Frejus
country: France
city: Freyming Merlebach
country: France
city: GAP
country: France
city: Gleize
country: France
city: Haguenau
country: France
city: Ivry Sur Seine
country: France
city: Laon
country: France
city: Lavaur
country: France
city: Le Bouscat
country: France
city: Le Coudray
country: France
city: Le Kremlin Bicetre
country: France
city: Libourne
country: France
city: Lievin
country: France
city: Lille
country: France
city: Limoges
country: France
city: Limoges
country: France
city: Lomme
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Maisons Laffitte
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Metz Tessy
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Moulins
country: France
city: Mulhouse
country: France
city: Nanterre
country: France
city: Nantes
country: France
city: Narbonne
country: France
city: Nevers
country: France
city: Nice
country: France
city: Nimes
country: France
city: Orange
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perigueux
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Poissy
country: France
city: Pontoise
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rodez
country: France
city: Roubaix
country: France
city: Salon De Provence
country: France
city: St Brieuc
country: France
city: St Chamond
country: France
city: St Mande
country: France
city: St Priest En Jarez
country: France
city: Ste Maxime
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Thionville
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Valenciennes
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Villeneuve St Georges
country: France
city: Villeurbanne
country: France
city: Vlleneuve Sur Lot
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.