A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis

• Conditions: Rheumatoid Arthritis (RA); MedDRA version: 12.1Level: LLTClassification code 10039073Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2010-019935-37-FI
• Lead Sponsor: Roche Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-02
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

To be eligible for this trial, patients must meet all of the following inclusion criteria:
1. Able and willing to give written informed consent and comply with the requirements of the study protocol.
2. Patients with early RA of = 2 year disease duration (defined from the onset of symptoms) at the time of the baseline visit.
3. Patients who have received DMARDs (including MTX) = 3 months £ 7 months.
4. Receiving treatment on an outpatient basis
5. No previous biologic agent
6. DAS28 > 3.2 at screening and baseline visits
7. Swollen joint count (SJC) ³ 6 (66 joint count), and tender joint count (TJC) ³ 6 (68 joint count) both at screening and baseline visits.
8. Age ³ 18 years
9. Oral corticosteroids (£ 10 mg/day prednisone or equivalent) allowed.
10. Females of child-bearing potential and non sterilized males with female partners of childbearing potential may participate in this trial only if using a reliable means of
contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch,
spermicide and barrier, or IUD).
11. If female and of childbearing potential, the patient must have a negative serum pregnancy stick test at baseline.
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

General
1. Major surgery (including joint surgery) within eight weeks prior to screening or planned major surgery within six months after baseline.
2. Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma, and polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis,
pulmonary fibrosis or Felty’s syndrome). Secondary Sjögrens syndrome or nodulosis with RA is permitted.
3. Functional class III and 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 (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to assess the effect of TCZ in<br>combination with DMARDs or DMARDs alone on disease<br>remission in adult RA patients treated with DMARDs (including<br>MTX) for three to seven months and having inadequate response to<br>current treatment (DAS28>3.2).;Secondary Objective: ;Primary end point(s): Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at 12 months.