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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01878318
• Other study ID #: ML28204
• Status: Withdrawn
• Phase: Phase 4
• First received: June 6, 2013
• Last updated: November 1, 2016
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Instituto Nacional de Higiene Rafael Rangel (INHRR)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• methotrexate
stable dose
• tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks, 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale		from baseline to Week 24	No
Secondary	Radiological changes in the hand according to the modified Sharp scale		from baseline to Week 24	No
Secondary	Change in Ritchie articular index		from baseline to Week 24	No
Secondary	Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24		Weeks 12 and 24	No
Secondary	Change in pain: Visual analogue scale (VAS)		from baseline to Week 24	No
Secondary	Change in disability: Stanford Health Assessment Questionnaire		from baseline to Week 24	No
Secondary	Change in FACIT-fatigue questionnaire		from baseline to Week 24	No
Secondary	Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)		from baseline to Week 28	No
Secondary	Change in C-reactive protein		from baseline to Week 24	No
Secondary	Change in immunologic parameters: Rheumatic factor/anti-CCP		from baseline to Week 24	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No