A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)
1 other identifier
interventional
201
1 country
28
Brief Summary
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 rheumatoid-arthritis
Started Oct 2009
Shorter than P25 for phase_4 rheumatoid-arthritis
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 16, 2009
CompletedStudy Start
First participant enrolled
October 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2011
CompletedResults Posted
Study results publicly available
July 2, 2014
CompletedMarch 29, 2018
February 1, 2018
1.3 years
October 15, 2009
April 7, 2014
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Health Assessment Questionnaire (HAQ) Score
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.
Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Weeks 4, 8, 12, 16, 20, and 24
Change in HAQ Score at Week 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Baseline and Week 24
Secondary Outcomes (13)
Pain Score as Assessed by Visual Analogue Scale (VAS)
Weeks 0, 4, 8, 12, 16, 20, and 24
European Quality of Life - 5 Dimensions (EQ-5D) Score
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in EQ-5D Score at Week 24 From Baseline
Baseline and Week 24
General Health Score as Assessed by EQ-5D VAS
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
Weeks 0, 4, 8, 12, 16, 20, and 24
- +8 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>/= 18 years of age
- moderate to severe active rheumatoid arthritis of \>/=6 months duration
- inadequate clinical response to current non-biologic DMARDs
- current DMARDs must be at stable dose for 8 weeks prior to study entry
- oral corticosteroids (\</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for \>/=4 weeks prior to screening
You may not qualify if:
- rheumatic autoimmune disease other than RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any biologic DMARD
- functional class IV as defined by the ACR classification
- intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Chelyabinsk Regional Clinical Hospital; Rheumatology
Chelyabinsk, 454076, Russia
Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
Cherkess, 369000, Russia
Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
Irkutsk, 664047, Russia
Republican Clinicodiagnostic Center
Izhevsk, 426009, Russia
Kaliningrad Regional Clinical Hospital; Rheumatologic Department
Kaliningrad, 236016, Russia
War Veterans Regional Clinical Hospital;Therapy Department
Kemerovo, 650099, Russia
Kirov Regional Clinical Hospital; Reumatology Department
Kirov, 610028, Russia
GUZ Regional clinical hospital # 1
Krasnodar, 350086, Russia
GMU Kursk regional clinical hospital
Kursk, 305007, Russia
FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
Moscow, 115522, Russia
FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
Moscow, 115682, Russia
FGU Central Clinical Hospital with Polyclinic Administration President RF
Moscow, 121359, Russia
Head Clinical Hospital of Internal Affair Ministry of Russia
Moscow, 123060, Russia
Vladimirskiy Regional Scientific Research Inst.
Moscow, 129110, Russia
SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, 603126, Russia
Republican Hospital Named After V.A. Baranov
Petrozavodsk, 185019, Russia
Rostov State Medical University; Cardiorheumatology Department
Rostov-on-Don, 344022, Russia
Clinical hospital #1
Smolensk, 214001, Russia
Surgut Region Clinical Hospital
Surgut, 628408, Russia
Glpu Tjumen Regional Clinical Hospital #1
Tyumen, 625023, Russia
Republican clinical hospital named after G.G. Kuvatov
Ufa, 450005, Russia
State Institution of Healthcare Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063, Russia
GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological
Veliky Novgorod, 173008, Russia
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
Voronezh, 394066, Russia
Voronezh Regional Clinical Hospital #1
Voronezh, 394066, Russia
SHI Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062, Russia
Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
Yekaterinburg, 620102, Russia
Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept
Yekaterinburg, 620102, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 16, 2009
Study Start
October 31, 2009
Primary Completion
February 14, 2011
Study Completion
February 14, 2011
Last Updated
March 29, 2018
Results First Posted
July 2, 2014
Record last verified: 2018-02