Mode
Text Size
Log in / Sign up
Phase 3 Completed N=227 Treatment

A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants

Source: ClinicalTrials.gov NCT01941940 ↗
Enrolled (actual)
227
Serious AEs
7.5%
Results posted
Dec 2016
Primary outcomePrimary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 — -21.6 units on a scale — p=<0.0001

Summary

This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab (RoActemra), administered as monotherapy or in combination with methotrexate and/or other DMARDs, in participants with moderate to severe active RA.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
-21.6 <0.0001 sig
PRIMARY
Change From Baseline in CDAI at Week 20
-21.3
PRIMARY
Change From Baseline in CDAI at Week 16
-20.2
PRIMARY
Change From Baseline in CDAI at Week 12
-19.1
PRIMARY
Change From Baseline in CDAI at Week 8
-17.7
PRIMARY
Change From Baseline in CDAI at Week 4
-14.0
PRIMARY
Change From Baseline in CDAI at Week 2
-9.1 <0.0001 sig
SECONDARY
Number of Participants Achieving Clinical Remission According to CDAI up to Week 52
10
SECONDARY
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Weeks 2, 24, and 52
5.81; -1.5; -3.2; -3.6 <0.0001 sig
SECONDARY
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 24, and 52
48.70; -26.5; -38.9; -39.3 <0.0001 sig
SECONDARY
Percentage of Participants With an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
18.5; 6.3; 11.7; 8.3; 4.7; 65.6
SECONDARY
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
32.4; 50.5; 17.1; 13.5; 25.0; 61.5
SECONDARY
Change From Baseline in Total TJC at Weeks 2, 24, and 52
16.91; -5.4; -12.9; -16.5; 11.32; -3.7 <0.0001 sig
SECONDARY
Change From Baseline in Total SJC at Weeks 2, 24, and 52
9.53; -3.7; -8.3; -9.1; 7.90; -2.9 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameters: DAS28-ESR and CDAI, Assessed Using Correlation Coefficient
0.86514; 0.86944; 0.87301 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameters: DAS28-ESR and SDAI, Assessed Using Correlation Coefficient
0.88118; 0.87060; 0.81995 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameters: CDAI and SDAI, Assessed Using Correlation Coefficient
0.98602; 0.97515; 0.97389 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient
-1.02676; -1.31737; -1.50400; -1.71191; -1.54281; -1.43977 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient
-1.62883; -1.36226; -1.47781 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient
-9.65473; -10.67389; -13.38810; -13.18433; -11.95933; -11.18299 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient
-10.97686; -7.03184; -9.46563 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient
-9.44923; -10.74230; -13.31421; -14.19790; -12.65454; -11.78067 <0.0001 sig
SECONDARY
Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient
-11.73463; -7.32435; -9.64146 <0.0001 sig
SECONDARY
Percentage of DMARDs Dose Reductions and/or Discontinuation Events by Reasons
27.7; 9.5; 29.7; 31.1; 2.0
SECONDARY
Percentage of Non-DMARDs Dose Reductions and/or Discontinuation Events by Reasons
9.5; 1.3; 8.8; 73.7; 6.8
SECONDARY
Change From Baseline in PtGDA VAS Score at Weeks 2, 24, and 52
61.31; -10.6; -28.4; -38.4 <0.0001 sig
SECONDARY
Change From Baseline in PGDA VAS Score at Weeks 2, 24, and 52
57.36; -15.3; -38.0; -43.9 <0.0001 sig
SECONDARY
Participant Pain VAS Score at Weeks 2, 24, and 52
58.21; -11.4; -26.5; -36.0 <0.0001 sig
SECONDARY
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 24, and 52
1.04; -0.2; -0.4; -0.5 <0.0001 sig
SECONDARY
Missed Working Days Assessed Using Short Form-Health and Labor Questionnaire (SF-HLQ) Score at Weeks 24 and 52
6.4; 0.3
SECONDARY
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Total Score at Weeks 2, 24, and 52
72.41; -5.8; -11.1; -43.8 <0.0001 sig
SECONDARY
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Weeks 24 and 52
11.00; -0.7; -0.9 0.0045 sig
SECONDARY
Treatment Compliance, as Assessed Using Participant Diary Cards and Return Records
94.9; 94.7
SECONDARY
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) of Special Interest
7.5
SECONDARY
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Tocilizumab
2.6; 100.0; 1.7; 33.3; 1.2; 2.4
SECONDARY
Mean Tocilizumab Concentration
35.6; 46.4; 52.6; 55.2; 54.0; 24.8
SECONDARY
Mean Soluble Interleukin-6 Receptor (sIL-6R) Concentration
43.6; 543.9; 536.3; 557.8; 539.4; 329.1

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria
  • Moderate to severe RA (CDAI at least [>/=] 10 and DAS28 >/=3.2) at screening
  • Tumor necrosis factor inhibitors-inadequate responder (TNF-IR), methotrexate-inadequate responder (MTX-IR), and/or DMARDs-inadequate responder (DMARDs-IR)
  • Oral corticosteroids (less than or equal to [ /=4 weeks prior to baseline
  • Permitted non-biologic DMARDs are allowed if at a stable dose for >/=4 weeks prior to baseline
  • Receiving treatment on an outpatient basis, not including tocilizumab
  • Females of childbearing potential and males with female partners of childbearing potential must agree to use a reliable means of contraception for at least 3 months following the last dose of tocilizumab

Exclusion Criteria

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following baseline
  • Rheumatic autoimmune disease other than RA; secondary Sjögren's syndrome with RA is permitted
  • Functional Class IV as defined by the ACR Classification of Functional Status in RA
  • Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
  • Prior history of or current inflammatory joint disease other than RA
  • Exposure to tocilizumab (either intravenous [IV] or SC) at any time prior to baseline
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
  • Previous treatment with any cell-depleting therapies
  • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
  • Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
  • Active tuberculosis (TB) requiring treatment within the previous 3 years
  • Positive for hepatitis B surface antigen or hepatitis C antibody
  • Primary or secondary immunodeficiency (history of or currently active)
  • Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years
  • Pregnant or breast feeding women
  • Neuropathies or other conditions that might interfere with pain evaluation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01941940). 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. Informational only — not medical advice.

Back to search