Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
CompletedResults postedLast updated 2 August 2017
What this trial tests
trial testing Tocilizumab in Rheumatoid Arthritis in 110 participants. Completed in 1 January 2015.
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)Primary· Up to 12 months
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well
AEs
Group
Value
95% CI
RA Cohort (Prospective + Retrospective)
31.8
SAEs
Group
Value
95% CI
RA Cohort (Prospective + Retrospective)
7.2
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every VisitSecondary· Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)
DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters \[mm\]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale \[VAS\]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*square root (√) of TJC + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher
Visit 3 (n=38)
Group
Value
95% CI
RA Cohort (Prospective)
55.3
Visit 4 (n=37)
Group
Value
95% CI
RA Cohort (Prospective)
73.0
Visit 5 (n=37)
Group
Value
95% CI
RA Cohort (Prospective)
81.1
Visit 6 (n=36)
Group
Value
95% CI
RA Cohort (Prospective)
80.6
Visit 7 (n=39)
Group
Value
95% CI
RA Cohort (Prospective)
84.6
Visit 8 (n=21)
Group
Value
95% CI
RA Cohort (Prospective)
90.5
Visit 9 (n=20)
Group
Value
95% CI
RA Cohort (Prospective)
85.0
Visit 10 (n=18)
Group
Value
95% CI
RA Cohort (Prospective)
88.9
Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)Secondary· Up to 12 months
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improv
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of \<3.2 Units at the time of assessment.
Visit 3 (n=38)
Group
Value
95% CI
RA Cohort (Prospective)
15.8
Visit 4 (n=37)
Group
Value
95% CI
RA Cohort (Prospective)
27.0
Visit 5 (n=37)
Group
Value
95% CI
RA Cohort (Prospective)
29.7
Visit 6 (n=36)
Group
Value
95% CI
RA Cohort (Prospective)
44.4
Visit 7 (n=39)
Group
Value
95% CI
RA Cohort (Prospective)
46.2
Visit 8 (n=21)
Group
Value
95% CI
RA Cohort (Prospective)
42.9
Visit 9 (n=20)
Group
Value
95% CI
RA Cohort (Prospective)
45.0
Visit 10 (n=18)
Group
Value
95% CI
RA Cohort (Prospective)
50.0
Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)Secondary· Up to 12 months
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value \<3.2 Units at the time of assessment. Time taken
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of \<2.6 units at the time of assessment.
Visit 3 (n=38)
Group
Value
95% CI
RA Cohort (Prospective)
5.3
Visit 4 (n=37)
Group
Value
95% CI
RA Cohort (Prospective)
10.8
Visit 5 (n=37)
Group
Value
95% CI
RA Cohort (Prospective)
16.2
Visit 6 (n=36)
Group
Value
95% CI
RA Cohort (Prospective)
30.6
Visit 7 (n=39)
Group
Value
95% CI
RA Cohort (Prospective)
35.9
Visit 8 (n=21)
Group
Value
95% CI
RA Cohort (Prospective)
28.6
Visit 9 (n=20)
Group
Value
95% CI
RA Cohort (Prospective)
35.0
Visit 10 (n=18)
Group
Value
95% CI
RA Cohort (Prospective)
38.9
Time Taken to Achieve Remission (DAS28 <2.6 Units)Secondary· Up to 12 months
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of \<2.6 units at the time of assessment. Time taken to achieve remission is reported.
Group
Value
95% CI
RA Cohort (Prospective)
130.31
28 – 252
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every VisitSecondary· Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 42), Visit 13 (Week 44)
ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every VisitSecondary· Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement.
CFB at Visit 3
Group
Value
95% CI
RA Cohort (Prospective)
-11.34
± 21.97
CFB at Visit 4
Group
Value
95% CI
RA Cohort (Prospective)
-18.67
± 26.29
CFB at Visit 5
Group
Value
95% CI
RA Cohort (Prospective)
-17.86
± 33.62
CFB at Visit 6
Group
Value
95% CI
RA Cohort (Prospective)
-24.51
± 35.40
CFB at Visit 7
Group
Value
95% CI
RA Cohort (Prospective)
-25.90
± 36.66
CFB at Visit 8
Group
Value
95% CI
RA Cohort (Prospective)
-27.20
± 37.13
CFB at Visit 9
Group
Value
95% CI
RA Cohort (Prospective)
-28.17
± 37.50
CFB at Visit 10
Group
Value
95% CI
RA Cohort (Prospective)
-27.25
± 37.07
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every VisitSecondary· Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)
The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as "maximum disease activity" (maximum arthritis disease activity).
CFB at Visit 3
Group
Value
95% CI
RA Cohort (Prospective)
-17.78
± 19.72
CFB at Visit 4
Group
Value
95% CI
RA Cohort (Prospective)
-23.56
± 24.64
CFB at Visit 5
Group
Value
95% CI
RA Cohort (Prospective)
-23.85
± 33.00
CFB at Visit 6
Group
Value
95% CI
RA Cohort (Prospective)
-29.06
± 33.91
CFB at Visit 7
Group
Value
95% CI
RA Cohort (Prospective)
-27.22
± 34.90
CFB at Visit 8
Group
Value
95% CI
RA Cohort (Prospective)
-29.00
± 35.51
CFB at Visit 9
Group
Value
95% CI
RA Cohort (Prospective)
-29.86
± 36.32
CFB at Visit 10
Group
Value
95% CI
RA Cohort (Prospective)
-28.68
± 35.95
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03787290 — Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder
· Phase 2
· suspended
NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu
· Phase 3
· recruiting
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
· not yet recruiting
NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra
· Phase 2
· not yet recruiting
NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post
· Phase 3
· recruiting
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis
· recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
· Phase 1
· recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel
· EARLY_PHASE1
· recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
· Phase 1
· recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O
· Phase 2
· not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in
· Phase 3
· recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations
· not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
· Phase 3
· recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric
· Phase 3
· recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 2 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01362062.