A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth

Phase 1

• Conditions: Adult Rheumatoid Arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-006040-79-DK
• Lead Sponsor: Aarhus University Hospital, Department of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-25
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients (>/= 18 years) with rheumatoid arthritis according to the ACR/EULAR (2010) classification criteria (1) who have been diagnosed • DAS28 score at baseline >/= 2.6
• Number of swollen joints >/= 1
• Receiving treatment on an outpatient basis
• Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine.
• Ability and willingness to give written informed consent and to meet the requirements of the trial 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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

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 Rheumatoid Arthritis
4. Prior history of or current inflammatory joint disease other than RA
5. Treatment with any investigational agent within 4 weeks (or 5 half-lives
of investigational agent, whichever is longer) of screening
6. Previous treatment with any TNF-a inhibitor, tocilizumab, rituximab and abatacept
7. Pregnant women or nursing (breastfeeding) mothers
8. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies incl. tocilizumab. Hypersensitivity to the active substance or to latex or any other excipients
9. Previous treatment with any cell-depleting therapy
10. Primary or secondary immunodeficiency (history of or currently active)
11. Known active current or history of recurrent infection (including TB)
12. Body weight of > 150 kg

Study & Design

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