Phase 4 N=54 Randomized Double-blind Treatment

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

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01034397 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Feb 2015

Primary outcome: Primary: 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 — -20.0; -37.5; -25.0; 0.0 percent change — p=1.00

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: tocilizumab [RoActemra/Actemra] (Drug); placebo (Drug); non-biological DMARDs (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	-20.0; -37.5; -25.0; 0.0; -23.6; -25.0	1.00
SECONDARY Percent Change From Baseline to Week 12 in OMERACT RAMRIS Score	-10.6; -15.4	0.421
SECONDARY Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Score	-5.5; -7.0	0.434
SECONDARY Percent Change From Baseline to Week 24 in OMERACT RAMRIS Score	-24.2; -17.3; -36.8	—
SECONDARY Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Score	-13.0; -3.0; -14.0	—
SECONDARY Absolute Change From Baseline to Week 12 in OMERACT-RAMRIS Synovitis Score	-1.0; -2.0; -1.0; 0.0; -2.0; -2.0	1.00
SECONDARY Absolute Change From Baseline to Week 24 in OMERACT-RAMRIS Synovitis Score	-1.0; -2.0; -2.0; -1.0; 0.0; -1.0	—
SECONDARY Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score	-3.7; 0.0	1.00
SECONDARY Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score	-0.5; 0.0	1.00
SECONDARY Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score	-6.6; -12.0; -5.0	—
SECONDARY Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score	-1.5; -2.0; -2.0	—
SECONDARY Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score	-17.1; -15.0	0.266
SECONDARY Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score	-3.0; -2.0	0.337
SECONDARY Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score	-37.5; -37.5; -51.9	—
SECONDARY Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score	-5.5; -3.0; -10.0	—
SECONDARY Percent Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score	-38.7; -12.1	0.114
SECONDARY Absolute Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score	-0.002; -0.001	0.239
SECONDARY Percent Change From Baseline to Week 24 in DCE-MRI EER Global Score	-45.4; 23.0; -32.7	—
SECONDARY Absolute Change From Baseline to Week 24 in DCE-MRI EER Global Score	-0.003; 0.0002; -0.002	—
SECONDARY Percent Change From Baseline to Week 12 in DCE-MRI EER MCP Score	-29.8; -10.9	0.271
SECONDARY Absolute Change From Baseline to Week 12 in DCE-MRI EER MCP Score	-0.002; -0.001	0.370
SECONDARY Percent Change From Baseline to Week 24 in DCE-MRI EER MCP Score	-32.3; 15.0; -29.1	—
SECONDARY Absolute Change From Baseline to Week 24 in DCE-MRI EER MCP Score	-0.002; 0.001; -0.001	—
SECONDARY Percent Change From Baseline to Week 12 in DCE-MRI EER Wrist Score	-24.8; -19.1	1.00
SECONDARY Absolute Change From Baseline to Week 12 in DCE-MRI EER Wrist Score	-0.002; -0.001	—
SECONDARY Percent Change From Baseline to Week 24 in DCE-MRI EER Wrist Score	-27.0; 1.4; -54.8	—
SECONDARY Absolute Change From Baseline to Week 24 in DCE-MRI EER Wrist Score	-0.002; 0.0001; -0.004	—
SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28)	5.7; 6.2; NA; 2.6; 5.6; NA	—
SECONDARY Change From Baseline to Week 12 in DAS28 Global Score	-2.99; 0.22	<0.001 sig
SECONDARY Change From Baseline to Week 24 in DAS28 Global Score	-3.4; -1.2; -2.9	—
SECONDARY Tender and Swollen Joint Counts	3.5; 8.0; NA; 1.0; 7.0; 5.5	—
SECONDARY Change From Baseline to Week 12 in TJC	-6.5; -2.0	0.067
SECONDARY Change From Baseline to Week 24 in TJC	-8.5; -5.0; -7.5	—
SECONDARY Change From Baseline to Week 12 in SJC	-7.0; -1.0	0.001 sig
SECONDARY Change From Baseline to Week 24 in SJC	-8.5; -7.0; -5.0	—
SECONDARY Change From Baseline to Week 12 in Patient Global Assessment of Disease Activity	-3.8; 0.2	0.002 sig
SECONDARY Change From Baseline to Week 24 in Patient Global Assessment of Disease Activity	-4.4; -1.5; -1.4	—
SECONDARY Patient Global Assessment of Pain	5.2; 5.1; NA; 3.2; 5.1; NA	<0.001 sig
SECONDARY Change From Baseline to Week 12 in Patient Global Assessment of Pain	-3.3; -0.3	0.007 sig
SECONDARY Change From Baseline to Week 24 in Patient Global Assessment of Pain	-3.7; -3.4; -1.5	—
SECONDARY Health Assessment Questionnaire - Disease Index (HAQ-DI) Scores	2.1; 2.3; NA; 1.5; 2.3; NA	—
SECONDARY Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)	-19.0; 2.0	0.001 sig
SECONDARY Change From Baseline to Week 24 in ESR	-20.0; -9.0; -27.0	—
SECONDARY Change From Baseline to Week 12 in C-Reactive Protein (CRP)	-0.9; -0.1	0.002 sig
SECONDARY Change From Baseline to Week 24 in CRP	-1.2; -0.2; -0.6	—
SECONDARY Change From Baseline to Week 12 in Serum Cortisol	-1.4; 2.5	0.118
SECONDARY Change From Baseline to Week 24 in Serum Cortisol	-2.5; -5.2; -5.1	—
SECONDARY Change From Baseline to Week 12 in Plasma Adrenocorticotrophic Hormone (ACTH)	0.00; 0.00	1.00
SECONDARY Change From Baseline to Week 24 in Plasma ACTH	-0.4; -0.3; 0.8	—
SECONDARY Change From Baseline to Week 12 in Serum Androstenedione	0.01; 0.01	0.437
SECONDARY Change From Baseline to Week 12 in 17 Hydroxy Progesterone (17OHP)	-0.01; -0.03	1.00
SECONDARY Change From Baseline to Week 24 in Serum Androstenedione	0.02; 0.01; -0.002	—
SECONDARY Change From Baseline to Week 24 in 17OHP	-0.01; -0.07; -0.02	—
SECONDARY Change From Baseline to Week 12 in Serum Dehydroepiandrosterone (DHEA)	-0.07; 0.00	0.190
SECONDARY Change From Baseline to Week 24 in Serum DHEA	0.17; -0.73; 0.40	—
SECONDARY Change From Baseline to Week 12 in Neuropeptide Y	-13.3; -0.7	0.051
SECONDARY Change From Baseline to Week 24 in Neuropeptide Y	-11.1; -2.5; -13.9	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01034397). 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.