Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
10 giugno 2015 aggiornato da: AbbVie (prior sponsor, Abbott)
Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy.
Participants started treatment with adalimumab under normal clinical settings in Germany.
Enrolled participants were followed during adalimumab therapy .
Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study.
Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
4681
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
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Participants with AS in routine clinical practice.
Descrizione
Inclusion Criteria:
- Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
- Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
- No contraindications for anti-tumor necrosis factors (TNF) therapy.
Exclusion Criteria:
1. Participants who do not meet the above listed inclusion criteria.
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
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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Ankylosing spondylitis
Participants with ankylosing spondylitis
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration.
It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0.
The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5.
The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25.
Data are reported as the mean change total score from baseline (Month 0).
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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The BASFI was a ten question, participant-reported measure that evaluated physical function.
Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7.
The mean of the ten questions was the total BASFI score.
Data are reported as the mean change of total score from baseline (Month 0).
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Number of Participants With Drug-Related Adverse Events (AEs)
Lasso di tempo: From signing of informed consent up to 24 months
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An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related.
This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal.
Exacerbations of pre-existing conditions are also considered adverse events.
Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.
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From signing of informed consent up to 24 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Number of Involved Peripheral Joints
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination.
Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants With Extraspinal Manifestations
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Erythrocyte Sedimentation Rate (ESR)
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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Mean Plasma Concentrations of C-Reactive Protein (CRP)
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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The BAS-G was a participant-reported instrument with two items.
In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months.
Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect).
The mean of the two scores was the total BAS-G score and the MCID was 1.5.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Global Assessment of Disease Activity Score
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity.
It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Participant Fatigue Score
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her.
It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Participant Pain Score
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her.
It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants With Morning Stiffness
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Morning stiffness was a participant-reported assessment.
The number of participants with morning stiffness were assessed at each visit.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Duration of Morning Stiffness
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours.
Data are reported as the mean duration of morning stiffness ± standard deviation.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria
Lasso di tempo: At 3, 6, 9, 12, 18, and 24 months
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This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst).
To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain.
To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.
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At 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants Achieving ASAS Partial Remission Criteria
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst).
To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit.
Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants on Adalimumab Monotherapy
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.
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At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Mean Equivalent Dose of Prednisolone
Lasso di tempo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department
Pubblicazioni e link utili
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Collegamenti utili
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 gennaio 2006
Completamento primario (Effettivo)
1 maggio 2014
Completamento dello studio (Effettivo)
1 maggio 2014
Date di iscrizione allo studio
Primo inviato
1 marzo 2010
Primo inviato che soddisfa i criteri di controllo qualità
2 marzo 2010
Primo Inserito (Stima)
3 marzo 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
9 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 giugno 2015
Ultimo verificato
1 giugno 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P10-147
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 .