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)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534311
• Other study ID #: ML29712
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: February 26, 2018
• Start date: October 13, 2015
• Est. completion date: December 1, 2015

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Slovakia, 

Outcome

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