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)

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 975 17
  • Bratislava, Slovakia, 826 06
  • Bratislava, Slovakia, 813 69
  • Nitra, Slovakia, 950 01
  • Piestany, Slovakia, 921 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe RA participants who are treated with tocilizumab

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tocilizumab; Participants will receive tocilizumab (162 milligrams [mg]) SC injection for 48 weeks.	Drug: Tocilizumab; Tocilizumab will be administered at 162 mg SC injection for 48 weeks.; Other Names: RoActemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average change from baseline in DAS28	up to Week 24
Average change from baseline in DAS28	up to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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
DAS28-joint count (C-reactive protein) [DAS28(CRP)] 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML29712