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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02648035
Date of registration:	05/01/2016
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis
Scientific title:	Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.
Date of first enrolment:	September 22, 2016
Target sample size:	200
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02648035
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Greece

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician
has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to
approved label within 4 weeks prior to enrolment.

Exclusion Criteria:

- Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to
enrolment.

- Participants who have received TCZ in past treatments.

- Participants who have received treatment with any investigational agent within 4 weeks
(or 5 half-lives of investigational agent, whichever is longer) of starting treatment
TCZ SC.

- Participants with a history of autoimmune disease or of any joint inflammatory disease
other than rheumatoid arthritis (RA).

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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Tocilizumab

Primary Outcome(s)

Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation [Time Frame: At 52 weeks]

Secondary Outcome(s)

Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale [Time Frame: At baseline, 24 and 52 weeks]

Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs) [Time Frame: At baseline, 24 and 52 weeks]

Percentage of Participants with Clinically Significant Changes in Laboratory Values [Time Frame: At baseline, 24 and 52 weeks]

Health Assessment Questionnaire (HAQ) Score [Time Frame: At baseline, 24 and 52 weeks]

Percentage of Participants on Glucocorticoids (GCs) with AEs [Time Frame: Up to 52 weeks]

Percentage of Participants with IEs with Laboratory Abnormalities [Time Frame: Up to 52 weeks]

Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs [Time Frame: Up to 52 weeks]

Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs) [Time Frame: Up to 52 weeks]

Visual Analog Scale (VAS) Pain Score in a 100 mm Scale [Time Frame: At baseline, 24 and 52 weeks]

Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR) [Time Frame: At baseline, 24 and 52 weeks]

Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy [Time Frame: At baseline, 24 and 52 weeks]

Disease Activity Score 28 (DAS28) [Time Frame: At baseline, 24 and 52 weeks]

Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs [Time Frame: Up to 52 weeks]

Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs [Time Frame: Up to 52 weeks]

Secondary ID(s)

ML29855

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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