--- title: An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice nct_id: NCT01474291 overall_status: COMPLETED sponsor: Hoffmann-La Roche study_type: OBSERVATIONAL primary_condition: Rheumatoid Arthritis countries: France canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01474291.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01474291" ct_last_update_post_date: 2016-10-28 last_seen_at: "2026-05-12T06:05:05.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT01474291](https://clinicaltrials.gov/study/NCT01474291) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 608 - **Lead Sponsor:** Hoffmann-La Roche - **Conditions:** Rheumatoid Arthritis - **Start Date:** 2012-01 - **Completion Date:** 2014-09 - **CT.gov Last Update:** 2016-10-28 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Tocilizumab** — Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice. ## Interventions - **Tocilizumab** (BIOLOGICAL) — Tocilizumab administered according to prescribing information and normal clinical practice. ## Primary Outcomes - **Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion** _(time frame: Day 1)_ — 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. ## Secondary Outcomes - **Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)** _(time frame: Day 1 (assessment of discontinuations within prior 2 years))_ - **Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide** _(time frame: Day 1 (assessment of discontinuations within prior 2 years))_ - **Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine** _(time frame: Day 1 (assessment of discontinuations within prior 2 years))_ - **Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine** _(time frame: 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)** _(time frame: Day 1 (assessment of discontinuations within prior 2 years))_ - **Mean Number of Tocilizumab Infusions Over the Study Period** _(time frame: Up to 30 months)_ - **Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period** _(time frame: Up to 13.4 months)_ - **Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period** _(time frame: Up to 30 months)_ - **Percentage of Participants With at Least One csDMARD Intensification During the Study** _(time frame: Up to 30 months)_ - **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** _(time frame: Month 12)_ - **Percentage of Participants With DAS28-ESR Remission at Month 12** _(time frame: Month 12)_ - **Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12** _(time frame: Month 12)_ - **Percentage of Participants With CDAI Remission at Month 12** _(time frame: Month 12)_ - **Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12** _(time frame: Month 12)_ - **Percentage of Participants With SDAI Remission at Month 12** _(time frame: Month 12)_ - **Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12** _(time frame: Month 12)_ - **Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12** _(time frame: Month 12)_ - **Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score** _(time frame: Baseline; Month 6; Month 12)_ - **Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score** _(time frame: Baseline; Month 6, Month 12)_ - **Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.** _(time frame: Baseline; Month 6; Month 12)_ - **Percentage of Participants With Adverse Events** _(time frame: Up to 30 months)_ ## Locations (119) - Aix-les-Bains, France - Amiens, France - Amiens, France - Angers, France - Auch, France - Aulnay-sous-Bois, France - Avignon, France - Bastia, France - Bayonne, France - Beauvais, France - Belfort, France - Belley, France - Berck, France - Besançon, France - Bobigny, France - Bois-Guillaume, France - Bondy, France - Bonneville, France - Bordeaux, France - Bordeaux, France - Boulogne-Billancourt, France - Bressuire, France - Brest, France - Bry-sur-Marne, France - Caen, France - Cahors, France - Cannes, France - Carcassonne, France - Chambray-lès-Tours, France - Chambray-lès-Tours, France - Châteauroux, France - Clermont-Ferrand, France - Colmar, France - Compiègne, France - Corbeil-essones, France - Corbeil-Essonnes, France - Créteil, France - Denain, France - Digne-les-Bains, France - Dijon, France - Dole, France - Draguignan, France - Druex, France - Échirolles, France - Épernay, France - Évian-les-Bains, France - Évreux, France - Évry, France - Freyming-Merlebach, France - Fréjus, France - Gap, France - Gleizé, France - Haguenau, France - Ivry-sur-Seine, France - Laon, France - Lavaur, France - Le Bouscat, France - Le Coudray, France - Le Kremlin-Bicêtre, France - Libourne, France - Liévin, France - Lille, France - Limoges, France - Limoges, France - Lomme, France - Lyon, France - Lyon, France - Maisons-Laffitte, France - Marseille, France - Marseille, France - Marseille, France - Metz-Tessy, France - Montauban, France - Montpellier, France - Moulins, France - Mulhouse, France - Nanterre, France - Nantes, France - Narbonne, France - Nevers, France - Nice, France - Nîmes, France - Orange, France - Paris, France - Paris, France - Paris, France - Paris, France - Paris, France - Paris, France - Perpignan, France - Périgueux, France - Pierre-Bénite, France - Poissy, France - Pontoise, France - Reims, France - Rennes, France - Rodez, France - Roubaix, France - Saint-Brieuc, France - Saint-Chamond, France - Saint-Mandé, France - Saint-Priest-en-Jarez, France - Salon-de-Provence, France - Ste Maxime, France - Strasbourg, France - Suresnes, France - Thionville, France - Toulon, France - Toulouse, France - Toulouse, France - Toulouse, France - Tourcoing, France - Valenciennes, France - Valenciennes, France - Vandœuvre-lès-Nancy, France - Vannes, France - Villeneuve-Saint-Georges, France - Villeurbanne, France - Vlleneuve Sur Lot, France ## Recent Field Changes (last 30 days) - `locations.|bastia||france` — added _(2026-05-12)_ - `locations.|avignon||france` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - 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`locations.|bressuire||france` — added _(2026-05-12)_ - `locations.|brest||france` — added _(2026-05-12)_ - `locations.|bry-sur-marne||france` — added _(2026-05-12)_ - `locations.|caen||france` — added _(2026-05-12)_ - `locations.|cahors||france` — added _(2026-05-12)_ - `locations.|cannes||france` — added _(2026-05-12)_ - `locations.|carcassonne||france` — added _(2026-05-12)_ - `locations.|chambray-lès-tours||france` — added _(2026-05-12)_ - `locations.|châteauroux||france` — added _(2026-05-12)_ - `locations.|clermont-ferrand||france` — added _(2026-05-12)_ - `locations.|colmar||france` — added _(2026-05-12)_ - `locations.|compiègne||france` — added _(2026-05-12)_ - `locations.|corbeil-essones||france` — added _(2026-05-12)_ - `locations.|corbeil-essonnes||france` — added _(2026-05-12)_ - `locations.|créteil||france` — added _(2026-05-12)_ - `locations.|denain||france` — added _(2026-05-12)_ - `locations.|digne-les-bains||france` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01474291.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01474291* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*