Clinical trial 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)
Official title: Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to severe RA participants who are treated with tocilizumab

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Average change from baseline in DAS28
timeFrame: up to Week 24
measure: Average change from baseline in DAS28
timeFrame: up to Week 48
Secondary outcomes:
measure: Percent of participants achieving clinical remission defined as a DAS28 <2.6
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: Percentage of participants achieving a DAS28 >=3.2
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: Evaluation of participant's pain using visual analogue scale (VAS)
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: Evaluation of the disease activity by participant using VAS
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: Evaluation of the disease activity by Doctor using VAS
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: DAS28-joint count (C-reactive protein) [DAS28(CRP)] score
timeFrame: Baseline, Week 12, 24, 36, and 48
measure: Absolute and percent change in the Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, Week 12, 24, 36, and 48
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Piestany
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: