- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01610791
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
8 luglio 2014 aggiornato da: Hoffmann-La Roche
A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)
This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs).
Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
121
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Casablanca, Marocco, 20000
-
Fés, Marocco, 30000
-
Khouribga, Marocco, 14000
-
Kénitra, Marocco, 25000
-
Marrakech, Marocco, 40000
-
Meknés, Marocco, 50000
-
Rabat, Marocco, 10000
-
Salé, Marocco, 15045
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
- Inadequate response to DMARDs
- Body weight < 150 kg
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
- Rheumatic autoimmune disease other than RA
- American College of Rheumatology (ACR) functional class IV
- Prior history of or current inflammatory joint disease other than RA
- Previous treatment with any biologic drug that is used in the treatment of RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Pregnant or lactating women
- Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Braccio singolo
|
8 mg/kg iv every 4 weeks, total of 6 infusions
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With Adverse Events
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Lasso di tempo: Weeks 4, 8, 12, 16, 20, and 24
|
Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.
|
Weeks 4, 8, 12, 16, 20, and 24
|
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
Lasso di tempo: Baseline through Week 24
|
The difference between baseline and highest values until Week 24 of ALT and AST.
The values are measures as international units per liter (UI/L).
The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.
|
Baseline through Week 24
|
Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
Lasso di tempo: Baseline through Week 24
|
Levels of LDL and TC were measured in milligrams/deciliter (mg/dL).
Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.
|
Baseline through Week 24
|
Percentage of Participants With Lipid Elevations by Study Visit
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL.
Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Percentage of Participants by DAS28 Response Category
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Time to Achieve Clinically Meaningful Reduction in DAS28
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units.
Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Participants with a DAS28 score <2.6 were considered to have achieved remission.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
Lasso di tempo: Weeks 4, 8, 12, 16, 20, and 24
|
The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)
|
Weeks 4, 8, 12, 16, 20, and 24
|
Swollen and Tender Joint Counts
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).
The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).
The change in SJC and TJC was determined as the difference in values from baseline at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Health Assessment Questionnaire (HAQ)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
HAQ was used to assess the physical ability and functional status of participants as well as quality of life.
The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities.
Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3).
The change in HAQ was determined as the difference in values from baseline at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Patient Global Assessment of Disease Activity (VAS)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS.
The left-hand extreme (0 mm) of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity" (maximum arthritis disease activity).
The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Physician's Global Assessment of Disease Activity (VAS)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS.
The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity".
The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician.
The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Patient Assessment of of Pain (VAS)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS.
The left-hand extreme (0 mm) of the line was described as "no pain" and the right-hand extreme of the line (100 mm) was described as "unbearable pain".
The change in participant's perception of pain was determined as the difference in values from baseline at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
C-Reactive Protein (CRP)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
CRP is an acute phase inflammatory marker.
Levels of CRP increase with inflammation.
The change in CRP was determined as the difference in values from baseline and at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Erythrocyte Sedimentation Rate (ESR)
Lasso di tempo: Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
ESR indirectly measures how much inflammation is in the body.
A higher ESR is indicative of increased inflammation.
The change in ESR was determined as the difference in values from baseline at each visit.
|
Baseline, Weeks 4, 8, 12, 16, 20, and 24
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2010
Completamento primario (Effettivo)
1 agosto 2011
Completamento dello studio (Effettivo)
1 agosto 2011
Date di iscrizione allo studio
Primo inviato
31 maggio 2012
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2012
Primo Inserito (Stima)
4 giugno 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 luglio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 luglio 2014
Ultimo verificato
1 luglio 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ML22638
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su tocilizumab [RoActemra/Actemra]
-
University of ChicagoAttivo, non reclutante
-
CelltrionNon ancora reclutamento
-
Hoffmann-La RocheCompletato
-
Hoffmann-La RocheCompletatoCOVID-19Spagna, Germania, Stati Uniti, Brasile, Italia, Francia, Grecia, Croazia, Polonia, Sud Africa, Regno Unito
-
Sun Yat-sen UniversityRitirato
-
Fundacion SEIMC-GESIDARoche Pharma AG; Dynamic Science S.L.Completato
-
Hoffmann-La RocheCompletato
-
University of OklahomaHoffmann-La RocheNon più disponibileArtrite idiopatica giovanileStati Uniti
-
University of ChicagoReclutamento
-
Reade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentReclutamentoArtrite reumatoideOlanda