Spondylitis, Ankylosing Clinical Trial
Official title:
A Multicenter Registry to Evaluate the Clinical Outcome of Chinese Adult Patients With Active Ankylosing Spondylitis Treated With Adalimumab in the Real World Practice
A multicenter registry to explore the clinical outcome of Chinese adult patients with active Ankylosing Spondylitis *AS* treated with adalimumab,prescribed according to the local label,in the real world practice
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients with established diagnosis of ankylosing spondylitis. 2. Patients eligible to use adalimumab according to the local label without any contraindication.(According to the local label, patients should be screened for active infection,TB,HBV,malignancy and CHF before the prescription of adalimumab,patients with latent TB should start a full course of anti-TB therapy before the use of adalimumab.) Exclusion Criteria: 1.Patients with contraindication or are not appropriate to use adalimumab according to the local label will be excluded |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of adalimumab, measured as percentage of patients achieving Bath Ankylosing Spondylitis Disease Activity Index *BASDAI* 50 at week12 with adalimumab treatment. | week12 | No | |
Secondary | Effectiveness of adalimumab measured as change in BASDAI,Ankylosing Spondylitis Disease Activity Scores *ASDAS*,Visual Analogue Scale *VAS* in pain,Patient Global Assessment *PtGA* with adalimumab treatment. | week 12 | No | |
Secondary | Proportion of patients who achieve each of the ASDAS disease state categories(inactive,mild,moderate,high) with adalimumab treatment. | week 12 | No | |
Secondary | Improvement of extra-articular manifestation with adalimumab treatment compared to baseline: uveitis flare rates, patient proportion with VAS scale at 1 in IBD PtGA, patient proportion with skin lesion clear or almost clear in psoriasis PGA. | Physician Global Assessment*PGA*. Inflammatory Bowel Disease *IBD* | week 12 | No |
Secondary | BASDAI50 response rate at week 26 and week52 in patients still on adalimumab compared to patients who discontinued adalimumab early. | week26 and 52 | No | |
Secondary | Change in BASDAI, ASDAS, and VAS in pain and PtGA in patients still on adalimumab compared to patients who discontinued adalimumab early. | week 26 and 52 | No | |
Secondary | Factors influencing the clinical response evaluated by the relapse rate(defined as BASDAI=4) after discontinuation of adalimumab in patients who achieved BASDAI <4 and do not restart biologics in the follow-up | week 52 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01208207 -
A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
|
Phase 3 | |
Completed |
NCT02509026 -
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
|
Phase 4 | |
Completed |
NCT02704845 -
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
|
N/A | |
Terminated |
NCT01209702 -
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
|
Phase 3 | |
Terminated |
NCT01209689 -
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy
|
Phase 3 | |
Terminated |
NCT00766402 -
An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
|
Phase 4 | |
Completed |
NCT00000433 -
Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
|
Phase 2 | |
Completed |
NCT00779012 -
A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)
|
Phase 4 | |
Completed |
NCT00779935 -
Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)
|
Phase 4 | |
Completed |
NCT01863732 -
Extension in AS: Sustainability of Benefits, Safety and Tolerability
|
Phase 3 | |
Recruiting |
NCT05879419 -
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
|
Phase 4 | |
Completed |
NCT01567878 -
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
|
N/A | |
Completed |
NCT01188655 -
Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
|
N/A | |
Completed |
NCT00760669 -
An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
|
Phase 4 | |
Completed |
NCT02159053 -
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
|
Phase 3 | |
Completed |
NCT00202865 -
Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)
|
Phase 3 | |
Completed |
NCT02374502 -
Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
|
N/A | |
Terminated |
NCT00273858 -
Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
|
N/A | |
Withdrawn |
NCT00298012 -
Methotrexate in the Treatment of Axial Spondyloarthritis
|
Phase 4 | |
Completed |
NCT04810715 -
Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis
|