Clinical trial NCT01664104: A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with moderate to severe RA who are being treated or begin treatment with tocilizumab according to routine clinical practice.

Brief summary: This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
* Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment

Exclusion Criteria:

* Participants who have started tocilizumab treatment more than 3 months prior to site opening
* Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
* Participants 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
* Participants with a history of autoimmune disease or joint inflammatory disease other than RA

Primary outcomes:
measure: Percentage of Participants on TCZ Treatment at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants by TCZ Dose at Month 6
timeFrame: Month 6
measure: Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
timeFrame: Baseline
measure: Time Elapsed From Diagnosis of RA
timeFrame: Baseline (assessed retrospectively)
measure: Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
timeFrame: Baseline
measure: Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline
timeFrame: Baseline
measure: Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline
timeFrame: Baseline
measure: Participant Assessment of Morning Stiffness Using VAS at Baseline
timeFrame: Baseline
measure: Participant Assessment of Fatigue Using VAS at Baseline
timeFrame: Baseline
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline
timeFrame: Baseline
measure: Tender Joint Count (TJC) at Baseline
timeFrame: Baseline
measure: Swollen Joint Count (SJC) at Baseline
timeFrame: Baseline
measure: Erythrocyte Sedimentation Rate (ESR) at Baseline
timeFrame: Baseline
measure: C-Reactive Protein (CRP) at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Evidence of Structural Joint Damage at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline
timeFrame: Baseline
measure: Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline
timeFrame: Baseline
measure: Percentage of Participants by Duration of Morning Stiffness at Baseline
timeFrame: Baseline
measure: Number of Participants With TCZ Dose Change According to the Reason for Change
timeFrame: Baseline up to Month 6
measure: Percentage of Participants by Number of TCZ Dose Modifications Per Participant
timeFrame: Baseline up to Month 6
measure: Time in Days Elapsed Between TCZ Infusions
timeFrame: Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8
measure: Percentage of Participants With TCZ Infusion Interruption
timeFrame: Baseline up to Month 6
measure: Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation
timeFrame: Baseline up to Month 6
measure: Percentage of Participants With TCZ Reintroduction
timeFrame: Baseline up to Month 6
measure: Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline
timeFrame: Baseline
measure: Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
timeFrame: Month 3 and Month 6
measure: Change From Baseline to Month 6 in TJC
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in SJC
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in PGH
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in PhGH
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in Patient's Assessment of Pain
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in HAQ-DI Score
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in Participant Assessment of Fatigue
timeFrame: Baseline and Month 6
measure: Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness
timeFrame: Baseline and Month 6
measure: Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI
timeFrame: Month 3 and Month 6
measure: Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
timeFrame: Month 3 and Month 6
measure: Time to DMARD Dose Reduction
timeFrame: Baseline up to Month 6
measure: Time to DMARD Dose Withdrawal
timeFrame: Baseline up to Month 6
measure: Percentage of Participants by Reason for DMARD Withdrawal During the Study
timeFrame: Baseline up to Month 6
measure: Time to Steroid Dose Reduction
timeFrame: Baseline up to Month 6
measure: Time to Steroid Dose Withdrawal
timeFrame: Baseline up to Month 6
measure: Change From Baseline in CRP at Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: Change From Baseline in ESR at Month 3 and Month 6
timeFrame: Baseline, Month 3, and Month 6
measure: CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
timeFrame: Baseline
measure: Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
timeFrame: Baseline
measure: Percentage of Participants With and Without Morning Stiffness
timeFrame: Month 3 and Month 6
measure: Percentage of Participants by Duration of Morning Stiffness
timeFrame: Month 3 and Month 6
measure: CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6
timeFrame: Baseline
measure: BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6
timeFrame: Baseline
measure: Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
timeFrame: Baseline and Month 6
measure: Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6
timeFrame: Baseline and Month 6
measure: Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6
timeFrame: Baseline and Month 6
measure: Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6
timeFrame: Baseline and Month 6
measure: Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
timeFrame: Baseline and Month 6
measure: Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6
timeFrame: Baseline and Month 6
measure: Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Coppito
country: Italy
state: Abruzzo
city: Reggio Calabria
country: Italy
state: Calabria
city: Benevento
country: Italy
state: Campania
city: Telese Terme
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Bergamo
country: Italy
state: Lombardia
city: Castel Goffredo
country: Italy
state: Lombardia
city: Gavardo
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Novara
country: Italy
state: Piemonte
city: Barletta
country: Italy
state: Puglia
city: Casarano (LE)
country: Italy
state: Puglia
city: Foggia
country: Italy
state: Puglia
city: Catania
country: Italy
state: Sicilia
city: Catania
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Cona (Ferrara)
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: