An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

Abbott

Status and phase

Completed

Phase 3

Conditions

Ankylosing Spondylitis

Treatments

Drug: adalimumab (Humira)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00478660

M05-760

Details and patient eligibility

About

Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study:

Subjects who failed another TNF inhibitor (etanercept, infliximab)
Subjects with advanced spinal ankylosis
Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

Enrollment

1,250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able and willing to give written informed consent and to comply with the requirements of the study protocol
Males and females 18 years of age or older
Diagnosis of AS according to the modified New York Criteria for Ankylosing Spondylitis 1984.24
Documented active AS based on the opinion of a physician for at least 3 months
Active AS with BASDAI >= 4 at the Screening Visit
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
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
Able and willing to self-administer sc injections or have available a suitable person to administer sc injections
A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment
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

Exclusion criteria

Prior treatment with any investigational agent within 30 days, or five half-lives of the product, which ever is longer
Treatment within the last six weeks with infliximab or within the last three weeks with etanercept or previous treatment at any time with adalimumab
Known allergy to excipients of adalimumab formulation
History of or current acute inflammatory joint disease of origin other than AS, e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus etc
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 sacroiliac joints without therapeutic response <=14 days before screening
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
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
History of positive serology for hepatitis B indicating active infection or history of positive serology for hepatitis C
History of positive HIV status
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
Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g., optic neuritis, ataxia, apraxia)
History of active tuberculosis, histoplasmosis or listeriosis
Female subjects who are pregnant or breast-feeding
History of clinically significant drug or alcohol abuse in the last year