Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2007-001377-28-FR
• Date of registration: 29/02/2008
• Prospective Registration: Yes
• Primary sponsor: Merck Serono International S.A.
• Public title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL
• Scientific title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL
• Date of first enrolment: 11/06/2008
• Target sample size: 92
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001377-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Control group of psoriasis subjects w/o thrombocytopenia (only for secondary objective)
• Phase: Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, France, Germany, Netherlands, Portugal

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria:
1) Subject participating to Study 25878 currently treated or having been treated with
efalizumab, with the last dose received within 6 weeks before inclusion in this trial.
2) Subject developing during the study 25878 either
- A newly diagnosed autoimmune disease (suspected or confirmed) such as
systemic lupus erythematosus, Wegener’s granulomatosis, antiphospholipid
syndrome, Sjögren syndrome, rheumatoid arthritis, multiple sclerosis, diabetes
type I, autoimmune uveoretinitis, autoimmune gut disorders such as Crohn
disease or ulcerative colitis, autoimmune vasculitis, autoimmune hepatitis,
autoimmune thyroiditis and other endocrine disorders, autoimmune haemolytic
anaemia, pernicious anaemia, myasthenia gravis, Goodpasture’s syndrome,
and Guillain-Barré syndrome, or
- A severe thrombocytopenia defined as grade III or IV according to NCICTCAE
criteria – i.e. platelet count < 50,000 mm3 - during routine monitoring
or for -cause laboratory evaluation
3) Subject is willing and able to participate in the trial and has provided signed, informed consent.
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In addition, for sites participating to the control group, control subjects will be included and must fulfil all the following criteria:
1) Subject participating to Study 25878
2) Absence of clinical signs of severe thrombocytopenia
3) Either currently treated with efalizumab or not (i.e. last dose of efalizumab received more than 6 weeks before study entry)
4) Subject is willing and able to participate in the trial and has provided signed, informed consent.

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:
1) Participation to any interventional clinical study (inclusion in other registry/ observational study is possible)
2) Administration of specific treatment for the current thrombocytopenia before inclusion in the study (e.g. glucocorticosteroids, plasmapheresis, platelet transfusion)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis
MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome
MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis
MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis
MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia
MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis
MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10

Intervention(s)

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: 1) To assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects treated with Raptiva® in the framework of the CLEAREST study:

- Subjects developing adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders including (but not limited to) systemic lupus erythematosus, Wegener’s granulomatosis, antiphospholipid syndrome, Sjögren syndrome, rheumatoid arthritis, multiple sclerosis, Type I diabetes, auto-immune uveoretinitis, auto-immune gut disorders such as Crohn disease or ulcerative colitis, auto-immune vasculitis, auto-immune hepatitis, auto-immune thyroiditis and other endocrine disorders, auto-immune haemolytic anaemia, pernicious anaemia, myasthenia gravis, Goodpasture’s syndrome, Guillain-Barré syndrome.

- Subjects developing severe thrombocytopenia (grade III or IV according to
National Cancer Institute – Common Toxicity Criteria for Adverse Events – i.e. platelet count <50,000/mm3)

Primary end point(s): Proportion of subjects with binding anti-efalizumab antibodies among subjects with
newly diagnosed autoimmune disorders and proportion of subjects with binding antiefalizumab antibodies among subjects who develop severe thrombocytopenia.

Secondary Objective: - To investigate thrombocytopenia mechanism of action in subjects who develop severe thrombocytopenia (defined as platelet count <50,000/mm3) in the context of previous Raptiva® treatment in the framework of the CLEAREST study. For this secondary objective, a control group of psoriasis subjects without severe thrombocytopenia will be included.
- To identify genetic profiles associated with drug-induced thrombocytopenia and autoimmune diseases.

Secondary ID(s)

27577

Ethics review

Status: Approved
Approval date: 11/06/2008
Contact:

Results

• Results available: Yes
• Date Posted: 02/01/2017
• Date Completed: 31/07/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001377-28/results