Ankylosing spondylitis patients (according to mod. New York criteria) who have have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms. MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Conditions
Interventions
Trade Name: Voltaren resinat
Product Name: Voltaren resinat
Product Code: not applicable
Pharmaceutical Form: Capsule, hard
Sponsors
Charité - Campus Mitte
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Diagnosis of AS according to the 1984 modified New York criteria [17] · Age 18 to 65 years. · Active disease defined by a score = 4 (VAS scale 0-10) of the BASDAI question 2 (related to back pain) at screening without NSAID therapy for at least 48 hours. · A clinical indication for NSAID therapy based on signs and symptoms. · The patient is able and willing to take oral medications. · The patient is capable of understanding and signing an informed consent form. The patient understands the study procedures, risks and benefits, and agrees to participate in the study giving written informed consent. · No current therapy with TNF agents. Any anti-TNF therapy must be stopped 4 weeks before screening. · In case of DMARD-therapy (methotrexate =25 mg/week, sulfasalazine =3 g/day, leflunomide, azathioprine, or hydroxychloroquine), the dose must be stable for 4 weeks prior to baseline. · In case of corticosteroid therapy, the dose must be stable within 2 weeks prior to baseline and must not exceed 10 mg (prednisolone equivalent) per day. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Complete ankylosis of the cervical and lumbar spine. · History of any illness or has significant abnormalities on pre-study clinical or laboratory evaluation that, in the opinion of the investigator, contraindicates continuous therapy for at least 2 years with diclofenac or any other NSAID. · History of oesophageal, gastric, pyloric channel or duodenal ulceration documented by endoscopy or radiographic examination at any time before the screening visit, or any clinically relevant gastrointestinal bleeding. · Clinical gastrointestinal malabsorption · History of or current signs of coronary heart disease, myocardial infarction, stroke or transient ischemic attack or thrombotic events. · Uncontrolled hypertension; · Evidence of impaired renal function, defined as serum creatinine > 1.5 mg/dl · History of inflammatory bowel disease (Crohn’ s disease, ulcerative colitis) · History of or current signs of bleeding diathesis · History of or current signs of peripheral arterial occlusive disease · Abnormal liver function (AST = 2x upper normal limit). Patients with known active hepatitis B or C must not participate. · Chronic or acute congestive heart failure (NYHA III or IV) · Patients with more than 2 risk factors for cardiovascular events (such as uncontrolled hypertension, hyperlipidemia, diabetes mellitus, smoking) in the past · Known reactions of bronchospasm, asthma, rhinitis or urticaria after intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past · Other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus, Sjögren’s syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis. · Any active infection · History of HIV infection. · History of neoplastic disease and does not meet one of the exceptions listed below. Patients with a history of leukaemia, lymphoma, melanoma, or myeloproliferative disease are ineligible for the study regardless of the time since treatment: Exceptions: Ø adequately treated basal cell carcinoma or carcinoma in situ of the cervix Ø other malignancies which have been successfully treated = 5 years prior to screening, where in the judgment of both the investigator and the treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. · History of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. · History of current evidence of abuse of “hard” drugs (e.g. cocaine/ heroine) or alcoholism. · Allergic to or has hypersensitivity to aspirin, diclofenac sodium, other NSAIDs, or coxibs. · Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test) · Patient is pregnant or nursing, or planning pregnancy within the projected duration of the study: Female patients of childbearing potential must have used adequate oral or barrier contraception or abstained from sexual contact at least 30 days prior to treatment and continue contraception through the treatment period or discontinuation visit. In addition, the patient must demonstrate a negative pregnancy test before baseline. Women who are postmenopausal, or surgically sterile (status posthysterectomy or who have had bilateral tubal ligation) are exempt from this requirement. Postmenopausal is defined as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess an effect of daily (continuous) versus on-demand NSAID (diclofenac) treatment on radiographic progression in AS patients at risk for radiographic progression. Radiographic change (mean) of the spine after 2 years will be assessed in the per-protocol population. ;Secondary Objective: Safety and the following efficacy data: the proportions of any progression (change in the mSASSS = 1) and change in the mSASSS > smallest detectable difference (SDC). Per protocol analysis of radiographic change. Change in VAS back pain, BASDAI, BASFI, BASMI, CRP;Primary end point(s): Assess an effect of daily (continuous) versus on-demand NSAID (diclofenac) treatment on radiographic progression in AS patients at risk for radiographic progression, radiographic change (mean) of the spine after 2 years in intention-to-treat popuatation as defined in the protocol. | — |
Countries
Germany
Outcome results
None listed