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

Hoffmann-La Roche0 sites60 target enrollmentOctober 13, 2015

ConditionsRheumatoid Arthritis

InterventionsTocilizumab

DrugsTocilizumab

Overview

Phase: Not Applicable
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 60
Primary Endpoint: Average change from baseline in DAS28
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 13, 2015

End Date

December 1, 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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)

Arms & Interventions

Tocilizumab

Participants will receive tocilizumab (162 milligrams \[mg\]) SC injection for 48 weeks.

Intervention: Tocilizumab

Outcomes

Primary Outcomes

Average change from baseline in DAS28

Time Frame: up to Week 48

Secondary Outcomes

Percent of participants achieving clinical remission defined as a DAS28 <2.6(Baseline, Week 12, 24, 36, and 48)
Percentage of participants achieving a DAS28 >=3.2(Baseline, Week 12, 24, 36, and 48)
Evaluation of participant's pain using visual analogue scale (VAS)(Baseline, Week 12, 24, 36, and 48)
Evaluation of the disease activity by participant using VAS(Baseline, Week 12, 24, 36, and 48)
Evaluation of the disease activity by Doctor using VAS(Baseline, Week 12, 24, 36, and 48)
DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score(Baseline, Week 12, 24, 36, and 48)
Absolute and percent change in the Health Assessment Questionnaire (HAQ)(Baseline, Week 12, 24, 36, and 48)
DAS28-joint count (C-reactive protein) [DAS28(CRP)] score(Baseline, Week 12, 24, 36, and 48)