An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01741688|
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : October 12, 2015
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Biological: Tocilizumab|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab|
|Actual Study Start Date :||October 26, 2012|
|Actual Primary Completion Date :||March 6, 2014|
|Actual Study Completion Date :||March 6, 2014|
Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Tocilizumab was administered according to the local label.
Other Name: Actemra
- Number of Participants on Tocilizumab at 6 Months After Treatment Initiation [ Time Frame: At 6 months ]
- Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis [ Time Frame: At baseline ]Systemic manifestation measured by C-reactive protein levels > 3
- Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure [ Time Frame: At baseline ]DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" includes participants, who were treated with DMARDs 6 months before being included in the study. "DMARDs treatment at baseline" includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab.
- Number of Participants Starting Tocilizumab After Failing Other Biologic Agents [ Time Frame: At baseline ]Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.
- Median Dose at 6 Months [ Time Frame: At 6 months ]
- Number of Participants With Dose Modifications at 6 Months [ Time Frame: At 6 months ]
- Median Duration of Treatment [ Time Frame: Approximately 16 months ]
- Percentage of Participants Discontinued From Tocilizumab for Safety [ Time Frame: Approximately 16 months ]Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.
- Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy [ Time Frame: Approximately 16 months ]Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.
- Number of Participants Discontinued From Tocilizumab for Other Reasons [ Time Frame: Approximately 16 months ]This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.
- Time to Restoration of Initial Dosing Regimen [ Time Frame: Approximately 16 months ]
- Non-adherence Rate of Physician to the Recommended Dosing Regimen [ Time Frame: Approximately 16 months ]
- Percentage of Participants on Tocilizumab Monotherapy at Study Entry [ Time Frame: At baseline ]
- Total Tender Joint Count (TJC) [ Time Frame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks ]
- Total Swollen Joint Count (SJC) [ Time Frame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks ]
- Disease Activity Score Based on 28 Joints (DAS28) [ Time Frame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks ]
The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad.
The Score is developed under the follow formula:
DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score.
This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741688
|ABK Reuma SRL- Medicentro BioCiencias|
|Lima, Peru, Lima 21|
|Hospital de la Mujer|
|Lima, Peru, Lima 34|
|Clinica San Borja; Servicio De Reumatologia|
|Lima, Peru, Lima 41|
|Clinica El Golf|
|San Isidro, Peru, L27 Lima|
|Study Director:||Clinical Trials||Hoffmann-La Roche|