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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02534311
• Date of registration: 25/08/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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)
• Scientific title: Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level
• Date of first enrolment: October 13, 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02534311
• Study type: Observational

Countries of recruitment

Slovakia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Average change from baseline in DAS28 [Time Frame: up to Week 24]

Average change from baseline in DAS28 [Time Frame: up to Week 48]

Secondary Outcome(s)

Absolute and percent change in the Health Assessment Questionnaire (HAQ) [Time Frame: Baseline, Week 12, 24, 36, and 48]

Percent of participants achieving clinical remission defined as a DAS28 <2.6 [Time Frame: Baseline, Week 12, 24, 36, and 48]

DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score [Time Frame: Baseline, Week 12, 24, 36, and 48]

Evaluation of participant's pain using visual analogue scale (VAS) [Time Frame: Baseline, Week 12, 24, 36, and 48]

Percentage of participants achieving a DAS28 >=3.2 [Time Frame: Baseline, Week 12, 24, 36, and 48]

Evaluation of the disease activity by Doctor using VAS [Time Frame: Baseline, Week 12, 24, 36, and 48]

DAS28-joint count (C-reactive protein) [DAS28(CRP)] score [Time Frame: Baseline, Week 12, 24, 36, and 48]

Evaluation of the disease activity by participant using VAS [Time Frame: Baseline, Week 12, 24, 36, and 48]

Secondary ID(s)

ML29712

Source(s) of Monetary Support

Please refer to primary and secondary sponsors