Clinical trial NCT01579006: Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Official title: A Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2012-04-17
Enrollment: 184
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: Rheumatoid arthritis patients treated with tocilizumab

Brief summary: This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
* Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Enrolled in an ongoing clinical trial and/or 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
measure: Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation
timeFrame: 5-6 months
Secondary outcomes:
measure: Percentage of Participants With Systemic Manifestations of RA at Baseline
timeFrame: Baseline
measure: Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study
timeFrame: Prior to study start (8 weeks) and Baseline up to 6 months
measure: Percentage of Participants With Reason for DMARD Withdrawal
timeFrame: Up to 6 months
measure: Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study
timeFrame: Prior to study start (8 weeks)
measure: Percentage of Participants With Type of Previous Biologic RA Treatments
timeFrame: Up to 6 months
measure: Duration of Previous Biologic RA Treatments
timeFrame: Up to 6 months
measure: Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
timeFrame: Up to 6 months
measure: Percentage of Participants With Dose Modifications
timeFrame: 6 months
measure: Percentage of Participants With Reasons for Dose Modification
timeFrame: 6 months
measure: Mean Dose at 6 Months
timeFrame: 6 months
measure: Mean Number of Dose Modifications at 6 Months
timeFrame: 6 months
measure: Mean Dosing Interval of Treatment at 6 Months
timeFrame: 6 months
measure: Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy
timeFrame: 6 months
measure: Time to Restoration of Initial Dosing Regimen
timeFrame: 6 months
measure: Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician
timeFrame: 6 months
measure: Percentage of Participants on TCZ Monotherapy
timeFrame: Up to 6 months
measure: Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6
timeFrame: Baseline, 6 months
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6
timeFrame: 6 months
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6
timeFrame: Baseline, 6 months
measure: Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6
timeFrame: 6 months
measure: Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6
timeFrame: 6 months
measure: Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6
timeFrame: 6 months
measure: Change From Baseline in CRP at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in ESR at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in PhGH at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in PGH of Disease Activity at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in HAQ-DI at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6
timeFrame: Baseline, 6 months
measure: Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6
timeFrame: Baseline, 6 months
measure: Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6
timeFrame: Administration 1 (Baseline), 6 months
measure: Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Afula
country: Israel
city: Beer Sheva
country: Israel
city: Beer Yaakov
country: Israel
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Ramat-Gan
country: Israel
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: