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Completed

NCT Number: NCT02534311

A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)

The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banská Bystrica, Slovakia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with age greater than or equal to (>=) 18 years
  • Participants with moderate to severe active RA (DAS28 >=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (DMARDs), irrespective of whether they were of biological or synthetic nature
  • Participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (SPC) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for RA in the past either
  • Assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient.
  • Pulmonologist's consent for chest X-ray and quantiferon test with commencement of biological treatment

Exclusion criteria

  • Hepatitis B surface antigen (HBsAg,) hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positivity
  • History of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies
  • History of intestinal ulcerations or diverticulitis
  • Active hepatopathy with more than threefold increase of alanine transaminase (ALT) or aspartate transaminase (AST)
  • Thrombocytes <100,000 per cubic milliliters (/mm^3), less than (<) 3,000 mm^3, absolute neutrophil count < 2,000 mm^3
  • Women of childbearing age (without medically confirmed sterility, e.g. following hysterectomy, ovariectomy, menopause lasting 2 years) who do not accept the use of a suitable form of contraception (e.g. barrier methods of contraception in the participant and partner, contraceptive pills or patches, hormonal implants, spermicidal agents in combination with barrier method of contraception, intrauterine device)

Treatment and study plan

Tocilizumab

Drug

Tocilizumab will be administered at 162 mg SC injection for 48 weeks.

Other names: RoActemra

Primary outcomes

  1. Average change from baseline in DAS28

    Time frame: up to Week 24

  2. Average change from baseline in DAS28

    Time frame: up to Week 48

Secondary outcomes

  1. Percent of participants achieving clinical remission defined as a DAS28 <2.6

    Time frame: Baseline, Week 12, 24, 36, and 48

  2. Percentage of participants achieving a DAS28 >=3.2

    Time frame: Baseline, Week 12, 24, 36, and 48

  3. Evaluation of participant's pain using visual analogue scale (VAS)

    Time frame: Baseline, Week 12, 24, 36, and 48

  4. Evaluation of the disease activity by participant using VAS

    Time frame: Baseline, Week 12, 24, 36, and 48

  5. Evaluation of the disease activity by Doctor using VAS

    Time frame: Baseline, Week 12, 24, 36, and 48

  6. DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score

    Time frame: Baseline, Week 12, 24, 36, and 48

  7. DAS28-joint count (C-reactive protein) [DAS28(CRP)] score

    Time frame: Baseline, Week 12, 24, 36, and 48

  8. Absolute and percent change in the Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, Week 12, 24, 36, and 48

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2015
Registry last updated
Feb 28, 2018

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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