- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01671059
A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)
6 januari 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
80
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Belgrade, Serbien, 11000
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Belgrade, Serbien, 11000
- Military Medical Academy; Clinic of Rheumatology
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Belgrade, Serbien, 11000
- Institut Za Reumatologiju; Reumatologiju
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Niska Banja, Serbien, 18205
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Niska Banja, Serbien, 18205
- Institute of Rheumatology and Cardiovascular Diseases; Rheumatology
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Novi Sad, Serbien, 21000
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Novi Sad, Serbien, 21000
- Special Hospital for Rheumatic Diseases Novi Sad
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Novi Sad, Serbien, 21000
- Clinical Center Voivodina; Clinic for Immunology and Nephrology
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Participants with rheumatoid arthritis initiated on treatment with tocilizumab (RoActemra/Actemra)
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Dose Modifications
Tidsram: 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)
Tidsram: 6 months
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6 months
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Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents
Tidsram: Baseline
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Baseline
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Reasons for Dose Modifications
Tidsram: 6 months
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6 months
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Percentage of Participants With Dose Interruptions
Tidsram: 6 months
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6 months
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Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
Tidsram: 6 months
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6 months
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Percentage of Participants on Tocilizumab Monotherapy at Study Entry
Tidsram: 6 months
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6 months
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Disease Activity Score Based on 28-Joint Count (DAS28)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
1 september 2015
Studieregistreringsdatum
Först inskickad
20 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
22 augusti 2012
Första postat (Uppskatta)
23 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 januari 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ML28314
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