An Observational Study to Evaluate RoActemra/Actemra (Tocilizumab) Treatment in a Real-Life Setting

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01664104

First received: August 7, 2012

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Purpose

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of RoActemra/Actemra (tocilizumab) therapy in a routine clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected for 6 months.

Condition
Rheumatoid Arthritis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Tocilizumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Dosage/schedule used in routine clinical practice [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical patient characteristics at the time of treatment initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Disease activity according to joint count evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Correlation of C-reactive protein and treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Correlation of body mass index (BMI) with treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety: incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Correlation of C-reactive protein with disability index/morning stiffness/VAS fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Correlation of body mass index with disability disability index/morning stiffness/VAS fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	June 2012
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with rheumatoid arthritis treated with RoActemra/Actemra according to routine clinical practice.

Criteria

Inclusion Criteria:

Adult patients, >/=18 years of age
Diagnosis of moderate to severe rheumatoid arthritis
Patients have started RoActemra/Actemra treatment according to routine clinical practice within 3 months prior to study start
Patients have been given oral and written information about the study and have signed the informed consent form

Exclusion Criteria:

Patients who have started RoActemra/Actemra treatment more than 3 months prior to site opening
Patients who have previously received RoActemra/Actemra in a clinical trial setting or for compassionate use
Patients who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
Patients with a history of autoimmune disease or joint inflammatory disease other than rheumatoid arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664104

Contacts

Contact: Please reference Study ID Number: ML28336 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

Italy
	Recruiting
Barletta (foggia), Italy, 76016
	Recruiting
Benevento, Italy, 82100
	Recruiting
Bergamo, Italy, 24128
	Recruiting
Bologna, Italy, 40138
	Recruiting
Casarano (le), Italy, 73042
	Recruiting
Castel Goffredo, Italy, 46042
	Recruiting
Catania, Italy, 95124
	Recruiting
Catania, Italy, 95126
	Recruiting
Cona (ferrara), Italy, 44124
	Recruiting
Coppito, Italy, 67100
	Recruiting
Firenze, Italy, 50139
	Recruiting
Foggia, Italy, 71100
	Recruiting
Gavardo, Italy, 25085
	Not yet recruiting
Iglesias (ci), Italy, 09016
	Recruiting
Milano, Italy, 20122
	Recruiting
Monza, Italy, 20052
	Not yet recruiting
Napoli, Italy, 80131
	Recruiting
Novara, Italy, 28100
	Not yet recruiting
Palermo, Italy, 90146
	Recruiting
Pavia, Italy, 27100
	Recruiting
Pisa, Italy, 56100
	Recruiting
Reggio Calabria, Italy, 89133
	Recruiting
Roma, Italy, 00128
	Recruiting
Telese Terme, Italy, 82037
	Recruiting
Verona, Italy, 37134
	Recruiting
Verona, Italy, 37126

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01664104 History of Changes
Other Study ID Numbers:	ML28336
Study First Received:	August 7, 2012
Last Updated:	May 7, 2013
Health Authority:	Italy: AIFA - Italian Medicines Agency

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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