Clinical trial NCT00996203: A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Health Assessment Questionnaire (HAQ) Score
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
measure: Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Change in HAQ Score at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Pain Score as Assessed by Visual Analogue Scale (VAS)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: European Quality of Life - 5 Dimensions (EQ-5D) Score
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Change in EQ-5D Score at Week 24 From Baseline
timeFrame: Baseline and Week 24
measure: General Health Score as Assessed by EQ-5D VAS
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Change in General Health Assessed by VAS
timeFrame: Baseline and Week 24
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Change in DAS28 Score From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: C-Reactive Protein
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Erythrocyte Sedimentation Rate
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital; Rheumatology
city: Cherkess
country: Russian Federation
facility: Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
city: Ekaterinburg
country: Russian Federation
facility: Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
city: Izhevsk
country: Russian Federation
facility: Republican Clinicodiagnostic Center
city: Kaliningrad
country: Russian Federation
facility: Kaliningrad Regional Clinical Hospital; Rheumatologic Department
city: Kemerovo
country: Russian Federation
facility: War Veterans Regional Clinical Hospital;Therapy Department
city: Kirov
country: Russian Federation
facility: Kirov Regional Clinical Hospital; Reumatology Department
city: Krasnodar
country: Russian Federation
facility: GUZ Regional clinical hospital # 1
city: Kursk
country: Russian Federation
facility: GMU Kursk regional clinical hospital
city: Moscow
country: Russian Federation
facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
city: Moscow
country: Russian Federation
facility: FGU Central Clinical Hospital with Polyclinic Administration President RF
city: Moscow
country: Russian Federation
facility: Head Clinical Hospital of Internal Affair Ministry of Russia
city: Moscow
country: Russian Federation
facility: Vladimirskiy Regional Scientific Research Inst.
city: Nizhny Novgorod
country: Russian Federation
facility: SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital Named After V.A. Baranov
city: Rostov-na-Donu
country: Russian Federation
facility: Rostov State Medical University; Cardiorheumatology Department
city: Smolensk
country: Russian Federation
facility: Clinical hospital #1
city: Surgut
country: Russian Federation
facility: Surgut Region Clinical Hospital
city: Tjumen
country: Russian Federation
facility: Glpu Tjumen Regional Clinical Hospital #1
city: UFA
country: Russian Federation
facility: Republican clinical hospital named after G.G. Kuvatov
city: Ulyanovsk
country: Russian Federation
facility: State Institution of Healthcare Ulyanovsk Regional Clinical Hospital
city: Veliky Novgorod
country: Russian Federation
facility: GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological
city: Voronezh
country: Russian Federation
facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1
city: Yaroslavl
country: Russian Federation
facility: SHI Yaroslavl Regional Clinical Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: