An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

NCT01543503 | Completed Results

• 1 other identifier: MA27950
• Study Type: observational
• Target: 1,225
• Locations: 16 countries
• Sites: 154

Brief Summary

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24

  Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker \[erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)\]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (\</=) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.

  Baseline and Week 24

Secondary Outcomes (19)

• Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52

  Baseline and Week 52

• Mean Change From Baseline in Erythrocyte Sedimentation Rate

  Baseline, Week 24, Week 52

• Mean Change From Baseline in C-reactive Protein

  Baseline, Week 24, Week 52

• Mean Change From Baseline in Swollen Joint Count

  Baseline, Week 24, Week 52

• Mean Change From Baseline in Tender Joint Count

  Baseline, Week 24, Week 52

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with rheumatoid arthritis

You may qualify if:

• Adult patients, \>/=18 years of age
• Diagnosis of rheumatoid arthritis
• Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy

You may not qualify if:

• Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
• Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
• Patients whose first biologic is rituximab, abatacept or anakinra.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (154)

Unknown Facility

Catamarca Capital, 4700, Argentina

Location

Unknown Facility

Mendoza, 5500, Argentina

Location

Unknown Facility

Mendoza, 5501, Argentina

Location

Unknown Facility

Rosario, S2000PBJ, Argentina

Location

Unknown Facility

Aalst, 9300, Belgium

Location

Unknown Facility

Assebroek, 8310, Belgium

Location

Unknown Facility

Aye, 6900, Belgium

Location

Unknown Facility

Brussels, 1000, Belgium

Location

Unknown Facility

Brussels, 1050, Belgium

Location

Unknown Facility

Edegem, 2650, Belgium

Location

Unknown Facility

Genk, 3600, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Godinne, 5530, Belgium

Location

Unknown Facility

Heusy, 4802, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

Unknown Facility

Ostend, 8400, Belgium

Location

Unknown Facility

Verviers, 4800, Belgium

Location

Unknown Facility

Westmalle, 2390, Belgium

Location

Unknown Facility

Barranquilla, Colombia

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Bucaramanga, Colombia

Location

Unknown Facility

Medellín, Colombia

Location

Unknown Facility

Cuenca, Ecuador

Location

Unknown Facility

Esmeraldas, EC080150, Ecuador

Location

Unknown Facility

Guayaquil, EC090114, Ecuador

Location

Unknown Facility

Portoviejo, Ecuador

Location

Unknown Facility

Quito, 005932, Ecuador

Location

Unknown Facility

Quito, EC170135, Ecuador

Location

Unknown Facility

Quito, EC170412, Ecuador

Location

Unknown Facility

Aachen, 52064, Germany

Location

Unknown Facility

Bad Aibling, 83043, Germany

Location

Unknown Facility

Bad Neuenahr-Ahrweiler, 53474, Germany

Location

Unknown Facility

Bayreuth, 95445, Germany

Location

Unknown Facility

Berlin, 13055, Germany

Location

Unknown Facility

Cologne, 50937, Germany

Location

Unknown Facility

Dresden, 01109, Germany

Location

Unknown Facility

Erfurt, 99096, Germany

Location

Unknown Facility

Erlangen, 91056, Germany

Location

Unknown Facility

Fulda, 36043, Germany

Location

Unknown Facility

Hamburg, 22147, Germany

Location

Unknown Facility

Hamburg, 22767, Germany

Location

Unknown Facility

Heidelberg, 69121, Germany

Location

Unknown Facility

Herne, 44652, Germany

Location

Unknown Facility

Ludwigsfelde, 14974, Germany

Location

Unknown Facility

München, 80639, Germany

Location

Unknown Facility

München, 81541, Germany

Location

Unknown Facility

Passau, 94032, Germany

Location

Unknown Facility

Rostock, 18059, Germany

Location

Unknown Facility

Stuttgart, 70178, Germany

Location

Unknown Facility

Traunstein, 83278, Germany

Location

Unknown Facility

Wuppertal, 42105, Germany

Location

Unknown Facility

Athens, 11527, Greece

Location

Unknown Facility

Athens, 155 62, Greece

Location

Unknown Facility

Pátrai, 26335, Greece

Location

Unknown Facility

Thessaloniki, 544 65, Greece

Location

Unknown Facility

Thessaloniki, 56429, Greece

Location

Unknown Facility

Guatemala City, Guatemala

Location

Unknown Facility

Coppito, Abruzzo, 67100, Italy

Location

Unknown Facility

Pescara, Abruzzo, 65100, Italy

Location

Unknown Facility

Brindisi, Apulia, 72100, Italy

Location

Unknown Facility

Martina Franca, Apulia, 74015, Italy

Location

Unknown Facility

San Cesario di Lecce, Apulia, 73016, Italy

Location

Unknown Facility

Reggio Calabria, Calabria, 89133, Italy

Location

Unknown Facility

Avellino, Campania, 83100, Italy

Location

Unknown Facility

Napoli, Campania, 80131, Italy

Location

Unknown Facility

Napoli, Campania, 80144, Italy

Location

Unknown Facility

Salerno, Campania, 84131, Italy

Location

Unknown Facility

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Unknown Facility

Rome, Lazio, 00133, Italy

Location

Unknown Facility

Rome, Lazio, 00189, Italy

Location

Unknown Facility

Arenzano, Liguria, 16011, Italy

Location

Unknown Facility

Brescia, Lombardy, 25123, Italy

Location

Unknown Facility

Legnano, Lombardy, 20025, Italy

Location

Unknown Facility

Milan, Lombardy, 20157, Italy

Location

Unknown Facility

Milan, Lombardy, 20162, Italy

Location

Unknown Facility

Agnone, Molise, 86081, Italy

Location

Unknown Facility

Turin, Piedmont, 10126, Italy

Location

Unknown Facility

Turin, Piedmont, 10128, Italy

Location

Unknown Facility

Catania, Sicily, 95124, Italy

Location

Unknown Facility

Jesi Ancona, The Marches, 60035, Italy

Location

Unknown Facility

Prato, Tuscany, 59100, Italy

Location

Unknown Facility

Perugia, Umbria, 06122, Italy

Location

Unknown Facility

Guadalajara, 44600, Mexico

Location

Unknown Facility

Guadalajara, 44650, Mexico

Location

Unknown Facility

Guadalajara, 45040, Mexico

Location

Unknown Facility

Mexicali, 21100, Mexico

Location

Unknown Facility

Mexico Ctiy, 07760, Mexico

Location

Unknown Facility

Panama City, 32400, Panama

Location

Unknown Facility

Almada, 2801-951, Portugal

Location

Unknown Facility

Amadora, 2720-276, Portugal

Location

Unknown Facility

Lisbon, 1069-166, Portugal

Location

Unknown Facility

Lisbon, 1649-035, Portugal

Location

Unknown Facility

Porto, 4099-001, Portugal

Location

Unknown Facility

Porto, 4200-319, Portugal

Location

Unknown Facility

Vila Nova de Gaia, 4400-129, Portugal

Location

Unknown Facility

Fuenlabrada, Madrid, 28942, Spain

Location

Unknown Facility

Madrid, Madrid, 28006, Spain

Location

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

Unknown Facility

Madrid, Madrid, 28905, Spain

Location

Unknown Facility

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Unknown Facility

Aarau, 5000, Switzerland

Location

Unknown Facility

Basel, 4031, Switzerland

Location

Unknown Facility

Chur, 7000, Switzerland

Location

Unknown Facility

Sankt Gallen, 9007, Switzerland

Location

Unknown Facility

Donetsk, 83045, Ukraine

Location

Unknown Facility

Kharkiv, 61052, Ukraine

Location

Unknown Facility

Kmelnytskyy, 29000, Ukraine

Location

Unknown Facility

Kyiv, 02125, Ukraine

Location

Unknown Facility

Kyiv, 03151, Ukraine

Location

Unknown Facility

Kyiv, 1023, Ukraine

Location

Unknown Facility

Odesa, 65026, Ukraine

Location

Unknown Facility

Uzhhorod, 88000, Ukraine

Location

Unknown Facility

Zaporizhzhya, 69600, Ukraine

Location

Unknown Facility

Barnsley, S75 2EP, United Kingdom

Location

Unknown Facility

Basildon, SS16 5NL, United Kingdom

Location

Unknown Facility

Basingstoke, RG24 9NA, United Kingdom

Location

Unknown Facility

Brighton, BN2 5BE, United Kingdom

Location

Unknown Facility

Cannock, WS11 5XY, United Kingdom

Location

Unknown Facility

Cardiff, CF14 4XW, United Kingdom

Location

Unknown Facility

Chertsey, KT16 0PZ, United Kingdom

Location

Unknown Facility

Crawley, RH11 7DH, United Kingdom

Location

Unknown Facility

Darlington, DL3 6HX, United Kingdom

Location

Unknown Facility

Enfield, EN2 8JL, United Kingdom

Location

Unknown Facility

Grimsby, DN33 2BA, United Kingdom

Location

Unknown Facility

Guildford, GU2 7XX, United Kingdom

Location

Unknown Facility

Ipswich, IP4 5PD, United Kingdom

Location

Unknown Facility

Kettering, NN16 8UZ, United Kingdom

Location

Unknown Facility

Lancaster, LA1 4RP, United Kingdom

Location

Unknown Facility

Leeds, LS7 4SA, United Kingdom

Location

Unknown Facility

Llandudno, LL30 1LB, United Kingdom

Location

Unknown Facility

London, SE18 4QH, United Kingdom

Location

Unknown Facility

London, SW17 0QT, United Kingdom

Location

Unknown Facility

London, W6 8RF, United Kingdom

Location

Unknown Facility

Luton, LU4 0DZ, United Kingdom

Location

Unknown Facility

Maidstone, ME16 9QQ, United Kingdom

Location

Unknown Facility

Margate, CT9 4AN, United Kingdom

Location

Unknown Facility

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

Unknown Facility

North Shields, NE29 8NH, United Kingdom

Location

Unknown Facility

Oswestry, SY10 7AG, United Kingdom

Location

Unknown Facility

Plymouth, PL6 8DH, United Kingdom

Location

Unknown Facility

Portsmouth, PO6 3LY, United Kingdom

Location

Unknown Facility

Reading, RG1 5AN, United Kingdom

Location

Unknown Facility

Rhyl, LL18 5UJ, United Kingdom

Location

Unknown Facility

Romford, RM7 0AG, United Kingdom

Location

Unknown Facility

Sheffield, S10 2JF, United Kingdom

Location

Unknown Facility

Stockport, SK2 7JE, United Kingdom

Location

Unknown Facility

Sunderland, SR4 7TP, United Kingdom

Location

Unknown Facility

Swindon, SN3 6BB, United Kingdom

Location

Unknown Facility

Torquay, TQ2 7AA, United Kingdom

Location

Unknown Facility

Warrington, WA5 1QG, United Kingdom

Location

Unknown Facility

Wolverhampton, WV10 0QP, United Kingdom

Location

Unknown Facility

Wrightington, WN6 9EP, United Kingdom

Location

Unknown Facility

Montevideo, 11000, Uruguay

Location

Unknown Facility

Montevideo, 11800, Uruguay

Location

Related Publications (1)

• Choy EH, Bernasconi C, Aassi M, Molina JF, Epis OM. Treatment of Rheumatoid Arthritis With Anti-Tumor Necrosis Factor or Tocilizumab Therapy as First Biologic Agent in a Global Comparative Observational Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1484-1494. doi: 10.1002/acr.23303. Epub 2017 Sep 6.

  PMID: 28622454 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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: February 28, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 10, 2016
• Results First Posted: February 10, 2016

Record last verified: 2016-01

Locations

PA (1); CH (4); GU (1); ME (5); GB (39); PT (7); GR (5); BE (14); UR (2); CO (4); ES (5); EC (7); AR (4); DE (22); IT (25); UA (9)