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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02534311
Other study ID # ML29712
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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