EUCTR2005-004826-21-GBActive, not recruitingNot Applicable
Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Abbott GmbH & Co. KG
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •A subject will be eligible for study participation if he/she meets all of the following
- •1. Able and willing to give written informed consent and to comply with the
- •requirements of the study protocol.
- •2. Males and females 18 years of age or older.
- •3. Diagnosis of AS according to the modified New York Criteria for Ankylosing
- •Spondylitis 1984.
- •4. Documented active AS based on the opinion of a physician for at least 3 months.
- •5. Active AS with BASDAI = 4 at the Screening Visit.
- •6. Unsatisfactory response to standard AS therapies in accordance with the current
- •national guidelines for treatment of AS with TNF inhibitors (if applicable)
- •including a minimum of failing at least one NSAID. National guidelines (if
- •applicable) must be followed if the guidelines are more strict regarding the use of
- •TNF inhibitors for the treatment of AS.
- •7. Use of reliable method of contraception, e.g., IUDs, condoms, or hormone (oral,
- •implantable, or injectable) contraceptives by all female subjects of childbearing
- •potential. Subject must follow the manufacture’s recommendations of
- •contraception prior to the administration of study drug and through 150 days
- •following the last administration of adalimumab.
- •8. Able and willing to self-administer sc injections or have available a suitable person
- •to administer sc injections.
- •9. A negative pregnancy test (serum HCG) for women of childbearing potential prior
- •to start of study treatment.
- •10. Subject must be evaluated for active and latent TB infection by using a PPD skin
- •test, T SPOT-TB test, chest x-ray and a detailed review of the subject's medical
- •history. Guidelines regarding the treatment of latent TB must be followed prior to
- •the administration of adalimumab.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •1. Prior treatment with any investigational agent within 30 days, or five half-lives of
- •the product, which ever is longer.
- •2. Treatment within the last two months with infliximab or within the last three
- •weeks with etanercept or previous treatment at any time with adalimumab.
- •3. Known allergy to excipients of adalimumab formulation.
- •4. History of or current acute inflammatory joint disease of origin other than AS, e.g.,
- •rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus etc.
- •5. Treatment with corticosteroids (prednisolone equivalents) under the following
- •conditions:
- •? Dose is >10 mg/d systemically within the 28 days before screening.
- •? Intraarticular injections or infiltrations of peripheral joints and tendons within
- •28 days before or at screening.
- •? Intraarticular injections of sacraliliac joints without therapeutic response <14
- •days before screening.
- •6. Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease,
- •congestive heart failure (NYHA III-IV), recent stroke (within three months),
- •chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which,
- •in the opinion of the investigator, would put the subject at risk by participation in
- •7. History of cancer or malignant lymphoproliferative disease other than a
- •successfully treated non-metastatic cutaneous squamous cell or basal cell
- •carcinoma and/or localized carcinoma in situ of the cervix.
- •8. History of positive serology for hepatitis B indicating active infection or history of
- •positive serology for hepatitis C.
- •9. History of positive HIV status.
- •10. Persistent or recurrent infections or severe infections requiring hospitalization or
- •treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior
- •to enrollment.
- •11. Previous diagnosis or signs highly indicative of central nervous system
- •demyelinating diseases (e.g., optic neuritis, ataxia, apraxia).
- •12. History of active tuberculosis, histoplasmosis or listeriosis.
- •13. Female subjects who are pregnant or breast-feeding.
- •14. History of clinically significant drug or alcohol abuse in the last year.
Investigators
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