A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.

• Conditions: Adult Rheumatoid Arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2011-002363-15-IS
• Lead Sponsor: Roche a/s

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-22
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Male or non-pregnant, non-nursing female
2. = 18 years of age
3. Receiving treatment on an outpatient basis
4. RA of = 6 months duration
5. Moderate to severe active RA: (DAS28 = 3.2)
6. Patients on = 1 non-biologic DMARDs and/or TNF?-inhibitor at a stable dose for a period = 8 weeks prior to treatment
7. Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy
8. If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment
9. Able and willing to give written informed consent and comply with the requirements of the study protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
2. Rheumatic autoimmune disease other than rheumatoid arthritis
3. Functional class IV as defined by the ACR Classification of Functional Status in
4. Prior history of or current inflammatory joint disease other than RA
Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
5. Previous treatment with rituximab and abatacept

6. Pregnant women or nursing (breastfeeding) mothers
7. Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD
8. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
9. Preivious treatment with any cell-depleting therapy
10. Preivious treatment with any tocilizumab
11. History of or currently active primary or secondary immunodeficiency
12. Known active current og history of recurrent infection (incliding TB)
13. Body weight of > 150 kg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: • To assess the incidence of discontinuations of TCZ due to AE and due to other causes.<br>• To assess the incidence of increase in ALT, AST and lipids<br>• To assess the number and % of patients achieving clinical remission (DAS28 < 2.6), LDA after 24 weeks.<br>• To assess the number and % of patients achieving ACR20, ACR50, ACR70 and ACR90 after 24 weeks<br>• To assess increase in HAQ after 24 weeks<br>;Primary end point(s): Infusion reactions as defined for the pivotale phase III trials. Infusion reactions are defined as any reaction that occurs during the infusion of tocilizumab or during the first 24 hours after the infusion. ;Timepoint(s) of evaluation of this end point: At every study visit;Main Objective: Incidence of infusion reactions