A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

NCT01034397 | Completed Phase 4 Results

• 2 other identifiers: ML226482009-012218-30
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 11

Brief Summary

This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Week 12 in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score

  Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th metacarpophalangeal (MCP) were assessed for synovitis via magnetic resonance imaging (MRI) and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.

  Week 12

Secondary Outcomes (56)

• Percent Change From Baseline to Week 12 in OMERACT RAMRIS Score

  Week 12

• Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Score

  Week 12

• Percent Change From Baseline to Week 24 in OMERACT RAMRIS Score

  Week 24

• Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Score

  Week 24

• Absolute Change From Baseline to Week 12 in OMERACT-RAMRIS Synovitis Score

  Week 12

Study Arms (2)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]; Drug: non-biological DMARDs

2

PLACEBO COMPARATOR

Drug: placebo; Drug: non-biological DMARDs

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks

1

placebo DRUG

iv every 4 weeks for 24 weeks

2

non-biological DMARDs DRUG

stable dose at investigator's prescription

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>/=18 years of age
• moderate to severe rheumatoid arthritis of \>/=6 months duration
• synovitis (swollen and tender joint) in the wrist of the dominant hand
• non-biologic DMARDs at stable dose for \>/=12 weeks prior to baseline
• oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

You may not qualify if:

• rheumatic autoimmune disease other than RA
• history of or current inflammatory joint disease other than RA
• functional class IV (ACR classification)
• intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• previous treatment with a biologic agent for RA

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Unknown Facility

Almada, 2801-951, Portugal

Location

Unknown Facility

Coimbra, 3000-075, Portugal

Location

Unknown Facility

Coimbra, 3041-801, Portugal

Location

Unknown Facility

Lisbon, 1050-34, Portugal

Location

Unknown Facility

Lisbon, 1069-639, Portugal

Location

Unknown Facility

Lisbon, 1349-019, Portugal

Location

Unknown Facility

Lisbon, 1649-035, Portugal

Location

Unknown Facility

Ponte de Lima, 4990-041, Portugal

Location

Unknown Facility

Porto, 4099-001, Portugal

Location

Unknown Facility

Porto, 4200-319, Portugal

Location

Unknown Facility

Vila Nova de Gaia, 4400-129, Portugal

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 29, 2018
• Results First Posted: February 6, 2015

Record last verified: 2018-02

Locations

PT (11)