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Completed

NCT Number: NCT01617005

A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Podgorica, 81000, Montenegro

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
  • Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
  • Initiating treatment with tocilizumab according to SPC

Exclusion criteria

  • Rheumatic autoimmune disease other than RA
  • Prior history or current inflammatory joint disease other than RA
  • Previous treatment with any biological drug used in the treatment of RA
  • Previous treatment with tocilizumab
  • Any contraindication to treatment with tocilizumab
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • Pregnant women or nursing (breastfeeding) mothers

Treatment and study plan

Tocilizumab

Drug

Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.

Other names: RoActemra, L04AC07

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: Baseline up to Week 24

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.

Secondary outcomes

  1. Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria

    Time frame: Baseline, Week 24

    EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.

  2. Number of Participants Who Discontinued Treatment Due to Lack of Efficacy

    Time frame: Baseline up to Week 24

  3. Time to Discontinuation Due to Lack of Efficacy

    Time frame: Baseline up to Week 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2012
Registry last updated
Dec 1, 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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