A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-01-17

Brief Summary

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This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[RoActemra/Actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab \[RoActemra/Actemra\] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tocilizumab

Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8 mg/kg intravenous infusion every 4 weeks.

Methotrexate

Intervention Type DRUG

methotrexate as per standard of care in clinical practice.

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg intravenous infusion every 4 weeks.

Intervention Type DRUG

Methotrexate

methotrexate as per standard of care in clinical practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients ≥ 18 years of age
* Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) \> 3.2 at screening)
* Patients with active RA after more than 12 weeks of treatment with DMARDs
* Patients with inadequate response to a stable dose of non-biologic DMARD

Exclusion Criteria

* Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Prior history of or current inflammatory joint disease other than RA

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No