Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02534311
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Tocilizumab

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level
Actual Study Start Date : October 13, 2015
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 1, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

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 Name: RoActemra




Primary Outcome Measures :
  1. Average change from baseline in DAS28 [ Time Frame: up to Week 24 ]
  2. Average change from baseline in DAS28 [ Time Frame: up to Week 48 ]

Secondary Outcome Measures :
  1. Percent of participants achieving clinical remission defined as a DAS28 <2.6 [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  2. Percentage of participants achieving a DAS28 >=3.2 [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  3. Evaluation of participant's pain using visual analogue scale (VAS) [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  4. Evaluation of the disease activity by participant using VAS [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  5. Evaluation of the disease activity by Doctor using VAS [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  6. DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  7. DAS28-joint count (C-reactive protein) [DAS28(CRP)] score [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]
  8. Absolute and percent change in the Health Assessment Questionnaire (HAQ) [ Time Frame: Baseline, Week 12, 24, 36, and 48 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Moderate to severe RA participants who are treated with tocilizumab
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534311


Locations
Layout table for location information
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 813 69
Bratislava, Slovakia, 826 06
Nitra, Slovakia, 950 01
Piestany, Slovakia, 921 01
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02534311     History of Changes
Other Study ID Numbers: ML29712
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases