Psoriatic Arthritis
Conditions
Interventions
Trade Name: Adalimumab
Product Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration nu
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females of 18yrs of age or more, with active psoriatic arthritis with 3 or more tender and swollen joints despite standard PsA therapy, who have had an unsatisfactory response or intolerance to at least 1 prior or ongoing DMARD. Females of childbearing capacity who have a negative pregnancy test at the start of treatment, and are on reliable contraception and females of non-childbearing capacity who are post-menopausal for atleast 1 year, or surgically sterile. Subjects who are able to self-administer the sc injections or who have suitable persons available to administer the injections for them, and subjects who are able and willing to give written informed consent and comply with the requirements of the study protocol. 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
Exclusion criteria: Subjects on prior treatment with any investigational agent within 30 days, or 5 half lives of the product, whichever is longer; those who have had treatment within the last 2 months with infliximab, or within the last 3 weeks with etanercept; treatment within the last 4 weeks with a combination of MTX and leflunomide or with a combination of cyclosporin with any other DMARD.Subjects who have received UVA phototherapy, including PUVA within 2 weeks prior to screening,subjects with a history of cancer or lymphoproliferative disease- except successfully and completely treated squamous cell or basal cell Ca. of skin or cervical dysplasia, with no recurrence within the last 2 years, history of or current acute inflammatory joint disease of origin other than PsA, uncontrolled diabetes, unstable ischaemic heart disease, congestive heart failure, active inflammatory bowel disease, recent stroke (within 3 months), chronic leg ulcer and any other comorbidities, latent TB.Subjects with positive serology for Hep B, history of positive HIV status,persistent or recurrent infections or severe infections requiring hospitalisation or treatment with antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment, subjects with a history of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the safety of adalimumab in PsA patients in a normal clinical setting. The patients may be on concomitant NSAID(s), steroids, one or more DMARDs, either as single treatment or in combination. Patients may have been previously treated and failed TNF-inhibitors (etanercept, infliximab). Also, to establish whether patients with moderate to severely active psoriatic arthritis will show response when adalimumab is added to the pre-existing insufficient standard psoriatic arthritis therapy. Efficacy profile will be compared for patients with concomitant DMARD(s) vs. adalimumab monotherapy. Efficacy will also be compared in patients with or without prior exposure to other TNF-inhibitors (etanercept, infliximab).;Secondary Objective: None;Primary end point(s): Safety:Adverse events, changes in laboratory parameters and vital signs will be collected, tabulated and analysed with descriptive statistics by concomitant DMARD(s) and by prior treatment with TNF-inhibitors vs adalimumab monotherapy. Efficacy:Response to adalimumab treatment will be measured at Week 12 by change of PsARC, ACR20, 50, 70 response criteria, change in DAS28, Physicians Global Assessment for Psoriasis (PGA), Psoriasis Target Lesion Assessment. Changes in physical function/ QoL from Baseline to Week 12 will be measured by HAQ and DLQI. | — |
Countries
Denmark, Finland, Germany, Ireland, Sweden, United Kingdom
Outcome results
None listed