Severe Chronic Plaque Psoriasis MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Trade Name: Adalimumab
Product Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
Abbott GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Psoriasis subjects with a PASI >50 at final visit for M02-529 or M03-596 2. Subjects who relapse after Week 24 in M02-538 3. Phase 3 subjects who meet the entry criteria specified in their preceeding Ph 3 protocol 4. Subjects over 18 years of age 5. If female subject is either not of childbearing poteintial, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tual ligation, bilateral oophorectomy or hysterectomy) or is of child-bearing potential and practising one of the following methods of birth-control throughout the study and for 150 days after the last dose of study drug: - condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) - contraceptives (oral or parenteral) for three months prior to study drug administration) - a vasecromized partner 6. If female of childbearing potential, results of the urine pregnancy test conducted at the last visit of the previous adalimumab study is negative or a serum pregnancy test is negative. 7. Subject is judged to be in generally good health as determined by the principal investigator based upon the results of laboratory evaluations and physical examinations done throughout the preceding psoriasis sstudy with adalimumab. 8. Subjects must be able and willing to gie written informed consent and comply with the requirements of this study protocol. 9. Subjects must be able to self-inject study medication or have a designee who can inject the study medication. 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: 1. The following subjects in a preceding psoriasis study with adalimumab are not eligible for enrollment in M03-658: a) M02-538 subjects who prematurely discontinue for reasons other than relapse b) M02-529 and M03-596 subjects who had a < PASI 50 at the final study visit c) subjects who complete the M02-538 360 day follow-up visit, and d) subjects who do not meet the requirements for entering M03-658 specified in their phase 3 protocol 2. For any reason, the subject is considered by the investigator to be an unsuitable candidate for continuing therapy in the M03-658 study 3. Subject has abnormal laboratory or other test values, that in the opinion of the investigator, would make it unsuitable for the subject to participate in this study. 4. Subject has other active skin diseases that may interfere with evaluation of psoriasis 5. Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug (see Table 3) including latex (a component of the syringe) 6. Subject must use topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids during the study. Subjects are allowed to use - Medicated shampoos that do not contain corticosteroids (i.e., shampoos containing tar, salicylic acid, or anthralin), - Bland (without beta, i.e. salicylic acid, or alpha hydroxy acids) emollients - low potency (calss VI or Vii) topical corticosteroids on the palms, soles, face, inframmatory area and groin only. See appendix K for a listing of examples of Class VI or VII topical corticosteroids 7. Subject cannot avoid UVB or UVA phototherapy, including PUVA, during the study 8. Subject cannot avoid excessive sun exposure or the use of tanning booths during the study 9. Subject may require systemic therapy known to improve psoriasis, other than study drug, during the trial 10. Subject has a poorly controlled medical condition, including unstable cardiovascular disease, recent stroke (within 3 months), advanced or poorly controlled diabetes, or documented history of recurrent infections 11. Subject has any underlying cardiac, pulmonary, metabolic, renal, or gastrointestinal condition, which in the opinion of the investigator, would make it unsuitable for the subject to participate in the study 12. History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease 13. History of cancer or 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 14. Subject has a history of active TB or listeriosis, or ongoing chronic or active infections requiring hospitalization or chronic use of an anti-infective agent 15. Use or planned use of anti-retroviral therapy at any time during the study 16. Subject is known to have immune deficiency or is immunocompromised 17. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study 18. Subject has a history of clinically significant drug or alcohol abuse in the last year 19. Subject has erythrodermic psoriasis or generalized pustular psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety, tolerability and clinical efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis entering from prior adalimumab psoriasis studies as well as examine the effectiveness of adalimumab retreatment following withdrawal from therapy and subsequent relapse (PGA >= 3) of psoriasis. Please refer to sections 5.3.2 and 5.3.3 of the study protocol for a detailed description of the study parameters.;Secondary Objective: None;Primary end point(s): Efficacy variables in Period O: 1. Proportion of subjects achieving PGA of 'clear' or 'minimal' at each visit. 2. Proportion of subjects achieving PASI 50/75/90/100 at each visit. Efficacy variables in Period W: 1. Proportion of subjects experiencing relapse (PGA >= 3) during Period W. 2. Time to relapse. 3. Time to loss of PGA 'clear' or 'minimal'. 4. Proportion of subjects achieving PGA of 'clear' or 'minimal' at each visit. 5. Proportion of subjects achieving PASI 50/75/90/100 at each visit. 6. Change and percent change from Week 0W in FACIT-Fatigue Scale at each visit. 7. Change from baseline Week 0W in DLQI at each visit. 8. Proportion of subjects with DLQI=0 at each visit. Efficacy variables in Period R: 1. Proportion of subjects regaining PGA of 'clear' or 'minimal' at each visit. 2. Proportion of subjects achieving PASI 50/75/90/100 at each visit. 3. Time to regain of PGA 'clear' or 'minimal'. 4. Change and percent change from Week 0W and from Week 0R in FACIT-Fatigue Scale at each visit. 5. Change from Week 0W and from Week 0R in DLQI at each visit. 6. Proportion of subjects with DLQI=0 at each visit. | — |
Countries
Germany, Spain
Outcome results
None listed