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)

NCT02534311 | Completed

• 1 other identifier: ML29712
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Average change from baseline in DAS28

  up to Week 24

• Average change from baseline in DAS28

  up to Week 48

Secondary Outcomes (8)

• 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

Study Arms (1)

Tocilizumab

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

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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

Also known as: RoActemra

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe RA participants who are treated with tocilizumab

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Unknown Facility

Banská Bystrica, 975 17, Slovakia

Location

Unknown Facility

Bratislava, 813 69, Slovakia

Location

Unknown Facility

Bratislava, 826 06, Slovakia

Location

Unknown Facility

Nitra, 950 01, Slovakia

Location

Unknown Facility

Piešťany, 921 01, Slovakia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 27, 2015
• Study Start: October 13, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

SL (5)