| Study name |
Optimising adalimumab treatment in psoriasis with concomitant methotrexate ‐ OPTIMAP |
| Methods |
Phase 4
RCT, placebo‐controlled, open‐label trial
Date of study: February 2014 ‐
Location: the Netherlands |
| Participants |
Randomised: number of participants not stated
Inclusion criteria
Diagnosis of moderate‐severe plaque psoriasis (PASI = 8 at time of screening) Candidate for the treatment with biologic drugs according to the pertaining guidelines Willing and able to use an adequate contraceptive during the study (all men and pre‐menopausal women) Adalimumab therapy will be started for the treatment of psoriasis Signed informed consent
Exclusion criteria
History of significant methotrexate or adalimumab toxicity, intolerability or contraindication Prior treatment with adalimumab Age < 18 years Pregnant and nursing women Other immunosuppressive medication (prednisone, mycophenolate mofetil (e.g. Cellcept), ciclosporin (e.g. Neoral), sirolimus (Rapamune), systemic tacrolimus (e.g. Prograft)
|
| Interventions |
Intervention
Adalimumab with methotrexate
Control intervention
Adalimumab monotherapy
Dosage and frequency of adalimumab and methotrexate: not stated |
| Outcomes |
Primary end point(s)
Timepoint(s) of evaluation of this end point: week 49
Secondary end point(s)
Efficacy expressed as the proportion of participants achieving PASI 75 and 90 at weeks 13, 25, 37 and 49 and reduction of absolute PASI at these time points Change in patient global assessment and IGA Average adalimumab serum trough concentrations and titers Change in impact on QoL (Skindex 29 and DLQI) Treatment satisfaction (measured by Treatment Satisfaction Questionnaire for Medication) Occurrence of (serious) AEs; Patient characteristics (age, gender, ethnicity, BMI, psoriatic arthritis, smoking, alcohol use, disease duration, disease severity by PASI, concomitant medication, naïve for biologics versus non‐naïve (perhaps specified per biologic), trial medication and potential other co‐variates (e.g. genetic polymorphisms)
Time point(s) of evaluation of this end point: week 13, 25, 37 and 49 |
| Starting date |
12 December 2013 |
| Contact information |
Pr Phyllis Spuls
Department of Dermatology Academic Medical Center
Meibergdreef 9 1105AZ Amsterdam Netherlands |
| Notes |
Recruitment status (ICTRP search portal): authorised‐recruitment may be ongoing or finished
Target sample: not specified
We emailed Prof. Phyllis Spuls (5 January 2017)
Email response "The study is currently ongoing and has not yet been analysed. Therefore, we are not able to provide data on efficacy or safety. We can provide you with the study protocol. Will this be helpful? Kind regards, Phyllis Spuls and Celine Busard "
Will be included when published |
