Clinical trial NCT01672970: A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With Tocilizumab.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 291
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: Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)

Brief summary: This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants With Systemic Manifestations of RA at Baseline
timeFrame: Baseline
measure: Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline
timeFrame: Prior to study (8 weeks) to Baseline
measure: Percentage of Participants With Reason for DMARDs Withdrawal at Baseline
timeFrame: Baseline
measure: Number of Previous Biologic RA Treatments Received by Participants
timeFrame: Baseline
measure: Percentage of Participants With Duration of Previous Biologic RA Treatments
timeFrame: Baseline
measure: Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
timeFrame: Baseline
measure: Number of Participants With Reasons for Dose Modification for TCZ
timeFrame: 6 months
measure: Mean Dose of TCZ at 6 Months
timeFrame: 6 months
measure: Mean Dosing Interval of Treatment at 6 Months
timeFrame: 6 months
measure: Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons
timeFrame: 6 months
measure: Number of Participants With Restoration of Initial Dosing Regimen of TCZ
timeFrame: 6 months
measure: Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ
timeFrame: 6 months
measure: Percentage of Participants on Tocilizumab Monotherapy
timeFrame: 6 months
measure: Percentage of Participants With Reason for DMARD Withdrawal
timeFrame: 6 months
measure: Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response
timeFrame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response
timeFrame: Baseline, 3 and 6 months
measure: Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response
timeFrame: Baseline, 3 and 6 months
measure: Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response
timeFrame: Baseline, 3 and 6 months
measure: Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
measure: Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Esztergom
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Heviz
country: Hungary
city: Kecskemet
country: Hungary
city: Kistarcsa
country: Hungary
city: Miskolc
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pécs
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: