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

• Register: EUCTR
• Last refreshed on: 22 July 2013
• Main ID: EUCTR2005-004826-21-FI
• Date of registration: 28/11/2005
• Prospective Registration: Yes
• Primary sponsor: Abbott GmbH & Co. KG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 20/01/2006
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004826-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
A subject will be eligible for study participation if he/she meets all of the following
criteria:
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 six weeks 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
the study.
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active Ankylosing Spondylitis

Intervention(s)

Product Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: To evaluate adalimumab 40 mg eow sc in subjects with active AS in day-to-day clinical practice. The safety and efficacy of adalimumab will be analyzed based on concomitant NSAID use, concomitant steroid use, concomitant DMARD use, and prior exposure to other TNF inhibitors (etanercept, infliximab). The safety and efficacy of adalimumab in subjects with AS will be evaluated based on the type of clinical presentation of the disease (axial, peripheral arthritis, and /or enthesitis). The number of subjects with total ankylosis of the spine was limited in previous phase 3 studies of adalimumab in AS, thus, limited experience is available for use of adalimumab in subjects with advanced, including total ankylosis of the spine. This study will allow for further analyses of safety and efficacy in subjects with advanced spinal ankylosis. The safety and efficacy profile will also be evaluated by AS associated disorders including inflammatory bowel disease, psoriasis and uveitis.

Primary end point(s): Not Applicable

Secondary Objective:

Secondary ID(s)

M05-760