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 - RHAPSODY

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2005-004826-21-IT
• Date of registration: 23/06/2006
• Prospective Registration: No
• Primary sponsor: ABBOTT
• 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 - 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 - RHAPSODY
• Date of first enrolment: 28/02/2006
• 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: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, 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 wiil 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 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 higly indicative of central nervous system demyelinating disease 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 significat drug of 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
MedDRA version: 6.1 Level: PT Classification code 10002556

Intervention(s)

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective:

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):

Secondary ID(s)

M05-760

2005-004826-21-FI