Ankylosing Spondylitis Clinical Trial
— SPAXIMOfficial title:
Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis
| Verified date | January 2017 |
| Source | University Hospital, Tours |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
There is a great individual variability of pharmacokinetic of infliximab in patients treated
for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate
(MTX), others have not.
Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties
of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 2009 |
| Est. primary completion date | October 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Ankylosing spondylitis - Needing anti-TNF drugs Exclusion Criteria: - Contra-indications to anti-TNF drugs |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital Jean MINJOZ -Besançon | Besancon | |
| France | University hospital of Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Tours | Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetic properties of infliximab in AS patients with or without methotrexate | 16 weeks | ||
| Secondary | Individual pharmacokinetic modelisation of infliximab | 16 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02685904 -
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis
|
Phase 3 | |
| Completed |
NCT02186873 -
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
|
Phase 3 | |
| Completed |
NCT01668004 -
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)
|
Phase 4 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Completed |
NCT01934933 -
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
|
Phase 4 | |
| Not yet recruiting |
NCT04875299 -
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
|
||
| Completed |
NCT02763111 -
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
|
Phase 2 | |
| Completed |
NCT02758782 -
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis
|
Phase 4 | |
| Active, not recruiting |
NCT02687620 -
Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
|
||
| Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
| Completed |
NCT01750528 -
Prevalence and Progression of Periodontitis in Ankylosing Spondylitis
|
N/A | |
| Completed |
NCT01463189 -
Web-based Support to Manage Arthritis Pain
|
Phase 2 | |
| Completed |
NCT01091675 -
Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs
|
Phase 3 | |
| Completed |
NCT00844805 -
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
|
Phase 3 | |
| Recruiting |
NCT00747578 -
Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan
|
N/A | |
| Completed |
NCT00715091 -
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis
|
Phase 4 | |
| Completed |
NCT01083693 -
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
|
N/A | |
| Not yet recruiting |
NCT00517101 -
Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy
|
N/A | |
| Completed |
NCT00367211 -
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
|
Phase 3 | |
| Completed |
NCT00133315 -
TNFalfa Blocking Treatment of Spondylarthropathies
|
Phase 4 |