- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01671059
A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)
6. ledna 2017 aktualizováno: Hoffmann-La Roche
A Multi-Center, Non-Interventional Study to Evaluate Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACROSS)
This non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis.
Eligible participants initiated on tocilizumab treatment according to the approved label were followed for 6 months.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
80
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Belgrade, Srbsko, 11000
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Belgrade, Srbsko, 11000
- Military Medical Academy; Clinic of Rheumatology
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Belgrade, Srbsko, 11000
- Institut Za Reumatologiju; Reumatologiju
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Niska Banja, Srbsko, 18205
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Niska Banja, Srbsko, 18205
- Institute of Rheumatology and Cardiovascular Diseases; Rheumatology
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Novi Sad, Srbsko, 21000
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Novi Sad, Srbsko, 21000
- Special Hospital for Rheumatic Diseases Novi Sad
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Novi Sad, Srbsko, 21000
- Clinical Center Voivodina; Clinic for Immunology and Nephrology
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
Participants with rheumatoid arthritis initiated on treatment with tocilizumab (RoActemra/Actemra)
Popis
Inclusion Criteria:
- Adult participants, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
- Participants in whom the treating physician made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit
Exclusion Criteria:
- Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit
- Participants who had previously received tocilizumab in a clinical trial or for compassionate use
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever was longer) before starting treatment with tocilizumab
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Tocilizumab
Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation
Časové okno: 6 months
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage of Participants With Dose Modifications
Časové okno: 6 months
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6 months
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Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Časové okno: 6 months
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6 months
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Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents
Časové okno: Baseline
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Baseline
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Reasons for Dose Modifications
Časové okno: 6 months
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6 months
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Percentage of Participants With Dose Interruptions
Časové okno: 6 months
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6 months
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Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
Časové okno: 6 months
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6 months
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Percentage of Participants on Tocilizumab Monotherapy at Study Entry
Časové okno: 6 months
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6 months
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Disease Activity Score Based on 28-Joint Count (DAS28)
Časové okno: 6 months
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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.
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6 months
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Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category
Časové okno: 6 months
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Percentage of participants achieving a response by EULAR category, including moderate, good, or no response.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached.
Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1;
No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.
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6 months
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Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category
Časové okno: 6 months
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Percentage of participants achieving a response by EULAR category, including moderate, good, or no response.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached.
Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1;
No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.
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6 months
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Simplified Disease Activity Index (SDAI)
Časové okno: 6 months
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Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28.
The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale [VAS]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L).
VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity).
Scores range from 0 to 86, with higher scores also indicating increased disease activity.
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6 months
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Clinical Disease Activity Index (CDAI) Score
Časové okno: 6 months
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Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA.
The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS.
VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity).
Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.
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6 months
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Percentage of Participants With American College of Rheumatology (ACR) Response
Časové okno: 6 months
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ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments.
A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR).
A reduction in the level of and acute phase reactants was considered an improvement.
ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively.
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6 months
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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)
Časové okno: 6 months
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An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.
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6 months
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Patient Global Assessment of Disease Activity Score
Časové okno: 6 months
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The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly.
A decrease in the score indicates improvement.
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6 months
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Health Assessment Questionnaire Disability Index (HAQ-DI)
Časové okno: 6 months
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The HAQ is a participant self-reported questionnaire for assessing the extent of the participant's functional ability.
It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities).
Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity.
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6 months
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Visual Analogue Scale (VAS) for Fatigue
Časové okno: 6 months
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The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue.
A decrease in the score indicates improvement.
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6 months
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Visual Analogue Scale (VAS) for Morning Stiffness
Časové okno: 6 months
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Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities.
Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
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6 months
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Visual Analogue Scale (VAS) for Pain
Časové okno: 6 months
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The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain.
A decrease in the score indicates improvement.
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6 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2012
Primární dokončení (Aktuální)
1. září 2015
Dokončení studie (Aktuální)
1. září 2015
Termíny zápisu do studia
První předloženo
20. srpna 2012
První předloženo, které splnilo kritéria kontroly kvality
22. srpna 2012
První zveřejněno (Odhad)
23. srpna 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. února 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. ledna 2017
Naposledy ověřeno
1. ledna 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ML28314
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .