Clinical trial NCT00754559: A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
Official title: "Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is \<500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* rheumatoid arthritis of \>=6 months duration diagnosed according to the revised 1987 ACR criteria;
* DAS28 of \>3.2;
* At screening either ESR \>=28 mm/h or CRP \>=1 mg/dL;
* Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
* functional class IV as identified by the ACR classification of functional status in RA;
* rheumatoid autoimmune disease other than RA;
* prior history of or current inflammatory joint disease other than RA.

Primary outcomes:
measure: Percentage of Participants With Low Disease Activity Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Absolute Changes in DAS28 From Baseline
timeFrame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category
timeFrame: Week 24
measure: Percentage of Participants With a DAS28 Response at Weeks 4 and 24
timeFrame: Weeks 4 and 24
measure: Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response
timeFrame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in Swollen and Tender Joint Counts at Week 24
timeFrame: Week 24
measure: Change From Baseline in the Levels of C-Reactive Protein at Week 24
timeFrame: Week 24
measure: Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score
timeFrame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in HAQ-DI at Week 24
timeFrame: Week 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24
timeFrame: Week 24
measure: Change From Baseline in Short Form-36 (SF-36) Score at Week 24
timeFrame: Week 24
measure: Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Duration of Morning Stiffness as Assessed Using PTHF
timeFrame: Baseline, Weeks 1, 2, and 4
measure: Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF
timeFrame: Baseline and Weeks 1, 2 and 4
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Score
timeFrame: Week 24
measure: Changes in Hemoglobin
timeFrame: Baseline, Weeks 1, 2, 4 and 24
measure: Changes in C-Reactive Protein
timeFrame: Baseline, Weeks 1, 2 ,4 and 24
measure: Changes in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Weeks 1, 2, 4 and 24
measure: Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response
timeFrame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Other outcomes:
Locations:
city: Aachen
country: Germany
city: Bad Abbach
country: Germany
city: Bad Aibling
country: Germany
city: Bad Bramstedt
country: Germany
city: Bad Nauheim
country: Germany
city: Baden-baden
country: Germany
city: Bayreuth
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Cuxhaven
country: Germany
city: Damp
country: Germany
city: Donaueschingen
country: Germany
city: Dresden
country: Germany
city: Dresden
country: Germany
city: Dresden
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Erfurt
country: Germany
city: Erlangen
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt Am Main
country: Germany
city: Frankfurt
country: Germany
city: Fulda
country: Germany
city: Gommern
country: Germany
city: Goslar
country: Germany
city: Grafschaft
country: Germany
city: Göttingen
country: Germany
city: Hagen
country: Germany
city: Halle
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Hildesheim
country: Germany
city: Hofheim
country: Germany
city: Homburg/saar
country: Germany
city: Hoyerswerda
country: Germany
city: Köln
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Ludwigsfelde
country: Germany
city: Ludwigshafen
country: Germany
city: Lüneburg
country: Germany
city: Mainz
country: Germany
city: Mainz
country: Germany
city: Marburg
country: Germany
city: Muenchen
country: Germany
city: München
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Naunhof
country: Germany
city: Neuss
country: Germany
city: Nürnberg
country: Germany
city: Oberammergau
country: Germany
city: Osnabrück
country: Germany
city: Pirna
country: Germany
city: Plochingen
country: Germany
city: Potsdam
country: Germany
city: Ratingen
country: Germany
city: Rostock
country: Germany
city: Sendenhorst
country: Germany
city: Stuttgart
country: Germany
city: Stuttgart
country: Germany
city: Treuenbrietzen
country: Germany
city: Tübingen
country: Germany
city: ULM
country: Germany
city: Wiesbaden
country: Germany
city: Würselen
country: Germany
city: Zeven
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: