Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
10 de junho de 2015 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Observacional
Inscrição (Real)
4681
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Participants with AS in routine clinical practice.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Caso-somente
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Ankylosing spondylitis
Participants with ankylosing spondylitis
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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).
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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)
Prazo: From signing of informed consent up to 24 months
|
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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Number of Involved Peripheral Joints
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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.
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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Mean Erythrocyte Sedimentation Rate (ESR)
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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)
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
|
|
Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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.
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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Mean Global Assessment of Disease Activity Score
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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.
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
|
Mean Participant Fatigue Score
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
|
|
Mean Participant Pain Score
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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).
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
|
Percentage of Participants With Morning Stiffness
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: 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
Prazo: 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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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Percentage of Participants on Adalimumab Monotherapy
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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)
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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.
|
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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Mean Equivalent Dose of Prednisolone
Prazo: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
|
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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2006
Conclusão Primária (Real)
1 de maio de 2014
Conclusão do estudo (Real)
1 de maio de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
1 de março de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de março de 2010
Primeira postagem (Estimativa)
3 de março de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
9 de julho de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2015
Última verificação
1 de junho de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P10-147
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .