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Completed

NCT Number: NCT01834807

A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis

This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.

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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

Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Diagnosis of rheumatoid arthritis
  • Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Exclusion criteria

  • Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
  • Patients that have started their current monotherapy before 01/01/2009

Treatment and study plan

Primary outcomes

  1. Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice

    Time frame: approximately 1 year

  2. Type of biological agents used in monotherapy in routine clinical practice

    Time frame: approximately 1 year

Secondary outcomes

  1. Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores

    Time frame: approximately 1 year

  2. Quality of life: HAQ-DI score

    Time frame: approximately 1 year

  3. Safety of biologics used in monotherapy: Incidence of adverse events

    Time frame: approximately 1 year

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Retrospective Study on the Use of Biologicals in Monotherapy in Rheumatoid Arthritis

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2013
Registry last updated
Nov 2, 2016

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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