Phase 3 N=105 Treatment

A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00951275 ↗

Enrolled (actual)

105

Serious AEs

3.8%

Results posted

Aug 2014

Primary outcome: Primary: Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin — 0.40 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: tocilizumab [RoActemra/Actemra] (Drug); Standard DMARDs (Disease Modifying Anti Rheumatic Drugs) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin	0.40	—
PRIMARY Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores	8.76	—
SECONDARY Mean Hemoglobin Levels During the Study	12.41; 12.84; 12.79; 12.95; 13.06; 13.10	—
SECONDARY Improvement of Anemia Assessed as Change From Baseline in Hemoglobin	0.47; 0.40; 0.56; 0.64; 0.62; 0.67	—
SECONDARY FACIT-F Scores	28.60; 35.54; 37.24; 39.16; 39.02; 40.21	—
SECONDARY Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores	7.11; 8.76; 10.74; 10.60; 11.47; 11.63	—
SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement	81.0; 59.0; 42.9	—
SECONDARY Percent Change From Baseline to Week 24 in TJC	-70.65	—
SECONDARY Percent Change From Baseline to Week 24 in SJC	-77.59	—
SECONDARY Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain	-52.25	—
SECONDARY Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity	-55.43	—
SECONDARY Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity	-65.89	—
SECONDARY Percent Change From Baseline to Week 24 in HAQ-DI	-45.94	—
SECONDARY Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)	-53.33	—
SECONDARY Percent Change From Baseline to Week 24 in ESR	-66.00	—
SECONDARY Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category	12.4; 23.8; 63.8	—
SECONDARY Percentage of Participants With a Response at Week 24 by DAS28 Category	49.5; 50.5	—
SECONDARY Percent Change From Baseline to Week 24 in DAS28 Score	-55.78	—
SECONDARY Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin	31.4	—
SECONDARY Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)	3.6; 11.8	—
SECONDARY Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ	-3.5; -4.2; -3.3; -6.1	—
SECONDARY Number of Hours as Assessed by SF-HLQ	13.6; 10.3; 0.2; 0.0; 1.1; 10.4	—
SECONDARY Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ	-8.9; -12.1; -4.4; -3.2; -0.1; -0.2	—
SECONDARY SF-HLQ Hindrance Score	0.9; 1.1; 1.0; 1.1; 0.6; 3.7	—
SECONDARY Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score	-0.30; -0.39; -0.40; -0.40; -0.40; -0.40	—
SECONDARY Efficiency as Assessed by SF-HLQ	6.3; 10.1	—
SECONDARY Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ	2.0; 2.2; -2.3; -2.7	—

Summary

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Eligibility Criteria

Inclusion Criteria

adult patients, >=18 years of age;
rheumatoid arthritis >=6 months duration;
DAS28>=3.2;
inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD therapy.

Exclusion Criteria

rheumatic autoimmune disease other than rheumatoid arthritis;
history of or current inflammatory joint disease other than rheumatoid arthritis;
unsuccessful treatment with an anti-TNF agent;
previous/concurrent treatment with any cell-depleting therapies.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00951275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.