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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01562327
Date of registration:	21/03/2012
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Scientific title:	A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra
Date of first enrolment:	February 2012
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01562327
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Argentina

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult participants, >/= 18 years of age

- Moderate to severe rheumatoid arthritis

- Participants initiating treatment with RoActemra/Actemra on their physician's decision
(in accordance with the local label), including participants 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

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation [Time Frame: 6 months after treatment initiation]

Secondary Outcome(s)

Reason for Biologic Agent Withdrawal at Baseline [Time Frame: Baseline]

Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

European League Against Rheumatism (EULAR) Response [Time Frame: Month 3, Month 6]

Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 [Time Frame: Month 3, Month 6]

Percentage of Participants Who Previously Received Biologic Agents [Time Frame: Baseline]

Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 [Time Frame: Month 3, Month 6]

Reason for DMARDs Withdrawal at Baseline [Time Frame: Baseline]

Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Baseline, Month 3, Month 6]

Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6 [Time Frame: Baseline, Month 3, Month 6]

Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab [Time Frame: Baseline]

Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab [Time Frame: Baseline]

Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy [Time Frame: Baseline, Month 6]

Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 [Time Frame: Month 3, Month 6]

Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy [Time Frame: Approximately 3 years]

Percentage of Participants Who Previously Received DMARDs [Time Frame: Baseline]

Simplified Disease Activity (SDAI) Response Classification [Time Frame: Month 3, Month 6]

Percentage of Participants With Systemic Manifestations of RA at Baseline [Time Frame: Baseline]

Percentage of Participants With an Adverse Event (AE) [Time Frame: approximately 3 years]

Reasons for Dose Modifications [Time Frame: approximately 3 years]

Secondary ID(s)

ML28142

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	18/10/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01562327

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