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A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: methotrexate (Drug); tocilizumab [RoActemra/Actemra] (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.

Clinical Details

Official title: Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale

Secondary outcome:

Radiological changes in the hand according to the modified Sharp scale

Change in Ritchie articular index

Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24

Change in pain: Visual analogue scale (VAS)

Change in disability: Stanford Health Assessment Questionnaire

Change in FACIT-fatigue questionnaire

Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)

Change in C-reactive protein

Change in immunologic parameters: Rheumatic factor/anti-CCP

Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of

>/= 6 months duration

- Active moderate to severe rheumatoid arthritis (DAS >/= 3. 2)

- Swollen joint count (SJC) >/= 6, tender joint count >/= 8

- Synovitis in the dominant hand

- Inadequate response to stable dose of a non-biological DMARD for at least 3 months

- Oral corticosteroids must have been on stable dose for at least 25 out of 28 days

before first dose of study drug

- Patient on outpatient treatment

Exclusion Criteria:

- Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned

major surgery within 6 months of randomization

- Rheumatic autoimmune disease other than rheumatoid arthritis

- American College of Rheumatology (ACR) functional class IV

- History of or current inflammatory joint disease other than rheumatoid arthritis

- Previous inadequate response to a biologic DMARD; prior biologic therapy for no

longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment

- Intra-articular or parenteral corticosteroids within 6 weeks prior to study start

- Inadequate hematologic, renal or liver function

- Positive for hepatitis B, hepatitis C or HIV infection

- Pregnant or lactating women

- History of severe allergic reactions or anaphylaxis to human, humanized or mural

monoclonal antibodies

- Current infections or history of recurrent infections

- History of or currently active primary or acquired immunodeficiency

- Active tuberculosis requiring treatment in the previous 3 years

- Body weight > 150 kg

Locations and Contacts

Additional Information

Starting date: June 2013
Last updated: August 17, 2015

Page last updated: August 20, 2015

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