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Completed

NCT Number: NCT02648035

EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Private Practice Rheumatology, Merantzis, Agrinio, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tocilizumab

Biological

Subcutaneous Tocilizumab according to approved label.

Other names: ACTEMRA

Primary outcomes

  1. Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation

    Time frame: At 52 weeks

Secondary outcomes

  1. Health Assessment Questionnaire (HAQ) Score

    Time frame: At baseline, 24 and 52 weeks

  2. Visual Analog Scale (VAS) Pain Score in a 100 mm Scale

    Time frame: At baseline, 24 and 52 weeks

  3. Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale

    Time frame: At baseline, 24 and 52 weeks

  4. Percentage of Participants with Clinically Significant Changes in Laboratory Values

    Time frame: At baseline, 24 and 52 weeks

  5. Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy

    Time frame: At baseline, 24 and 52 weeks

  6. Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)

    Time frame: At baseline, 24 and 52 weeks

  7. 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

  8. Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs

    Time frame: Up to 52 weeks

  9. Percentage of Participants with IEs with Laboratory Abnormalities

    Time frame: Up to 52 weeks

  10. 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

  11. Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs

    Time frame: Up to 52 weeks

  12. Percentage of Participants on Glucocorticoids (GCs) with AEs

    Time frame: Up to 52 weeks

  13. Disease Activity Score 28 (DAS28)

    Time frame: At baseline, 24 and 52 weeks

  14. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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