A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.
2 other identifiers
interventional
105
1 country
27
Brief Summary
This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Oct 2009
Shorter than P25 for phase_3 rheumatoid-arthritis
27 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
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedStudy Start
First participant enrolled
October 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2011
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedAugust 3, 2017
June 1, 2017
1.7 years
July 30, 2009
June 4, 2014
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin
Hemoglobin levels were measured as grams/deciliter (g/dL).
Week 4
Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.
Week 4
Secondary Outcomes (25)
Mean Hemoglobin Levels During the Study
Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
Improvement of Anemia Assessed as Change From Baseline in Hemoglobin
Weeks 2, 4, 8, 12, 16, 20, and 24
FACIT-F Scores
Baseline, Weeks 2, 4, 8,12, 16, 20 and 24
Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores
Weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement
Week 24
- +20 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- rheumatoid arthritis \>=6 months duration;
- DAS28\>=3.2;
- inadequate response to prior treatment with a stable dose (\>=8 weeks) of DMARD therapy.
You may not qualify if:
- rheumatic autoimmune disease other than rheumatoid arthritis;
- history of or current inflammatory joint disease other than rheumatoid arthritis;
- unsuccessful treatment with an anti-TNF agent;
- previous/concurrent treatment with any cell-depleting therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Ospedale Perrino; Medicina Interna - Divisione di Reumatologia
Brindisi, Apulia, 72100, Italy
Presidio Ospedaliero Valle D'itria; Divisione Di Nefrologia
Martina Franca, Apulia, 74015, Italy
Ospedale Galateo; U.O. Di Reumatologia
San Cesario di Lecce, Apulia, 73016, Italy
Azienda Ospedaliera Rummo; Divisione Di Reumatologia
Benevento, Campania, 82100, Italy
Azienda Ospedaliera A. Cardarelli; Medicina III - Divisione di Reumatologia
Napoli, Campania, 80131, Italy
UNIVERSITÀ DI NAPOLI FEDERICO II; Dipartimento di Immunologia Clinica ed Allergologia
Napoli, Campania, 80131, Italy
Ospedale M. Scarlato - Asl Sa1; U.O. Di Reumatologia
Scafati, Campania, 84018, Italy
Irccs Fondazione Salvatore Maugeri-Istituto Scientifico Di Telese;U.O. Riabilitazione Reumatologica
Telese Terme, Campania, 82037, Italy
A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2
Bologna, Emilia-Romagna, 40138, Italy
Az. Ospedaliera Univ. di Parma; Medicina Interna e Reumatologia
Parma, Emilia-Romagna, 43100, Italy
Ospedale Guglielmo Da Saliceto Unità Operativa Semplice di Reumatologia e Immunologia
Piacenza, Emilia-Romagna, 29100, Italy
Policlinico Tor Vergata; Divisione Di Reumatologia
Rome, Lazio, 00133, Italy
Ospedale Nuovo Regina Margherita; Divisione di Medicina Interna Reumatologia
Rome, Lazio, 00153, Italy
Ospedale S.Pietro Fatebenefratelli; Divisione di Reumatologia
Rome, Lazio, 00189, Italy
Ospedale Belcolle; Divisione Di Reumatologia
Viterbo, Lazio, 01100, Italy
Ospedale San Paolo; Divisione di Reumatologia
Savona, Liguria, 17100, Italy
ASST PAPA GIOVANNI XXIII; Reumatologia Day Hospital-Torre 2 terzo piano
Bergamo, Lombardy, 24127, Italy
ASST DI MONZA; Reumatologia (Medicina I)
Monza, Lombardy, 20052, Italy
IRCCS Istituto Clinico Humanitas; Immunologia Clinica E Reumatologia
Rozzano, Lombardy, 20089, Italy
Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica
Turin, Piedmont, 10154, Italy
Ospedale Vittorio Emanuele Ii; U.O. Reumatologia Clinica Medica Condorelli
Catania, Sicily, 95124, Italy
A.U.O. G. Martino- Policlinico Univ. Gazzi; Dept. Di Medicina Interna, Divisione Di Reumatologia
Gazzi, Sicily, 98125, Italy
Arnas Ospedale Civico; Medicina Interna II
Palermo, Sicily, 90127, Italy
Az. Osp. Villa Sofia; Unità Operativa Reumatologia
Palermo, Sicily, 90146, Italy
Ospedali Riuniti Villa Sofia- Cervello X; Divisione Medicina I
Palermo, Sicily, 90146, Italy
Ospedale Di Massa; Divisione Di Reumatologia
Massa, Tuscany, 54100, Italy
Ospedale SS Giovanni e Paolo; Divisione Di Reumatologia
Venezia, Veneto, 30127, Italy
MeSH Terms
Conditions
Interventions
Condition 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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2009
First Posted
August 4, 2009
Study Start
October 31, 2009
Primary Completion
July 22, 2011
Study Completion
July 22, 2011
Last Updated
August 3, 2017
Results First Posted
August 12, 2014
Record last verified: 2017-06