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CLEAR - Psoriasis

Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study.

    Status Active, enrolment terminated
    Related Conditions

Enrollment Details

200 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
W14-406

Brief summary

Top

The purpose of this study is to determine the safety and efficacy of the use of the combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in suboptimal responders to ADA monotherapy.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 23

0
Barrie, ON
1
Barrie, ON
2
Bathurst, NB
3
Calgary, AB
4
Edmonton, AB
5
Edmonton, AB
6
Hamilton, ON
7
Markham, ON
8
Ottawa, ON
9
Peterborough, ON
10
Richmond Hill, ON
11
Saint-Jérôme, QC
12
St John's, NL
13
St John's, NL
14
St John's, NL
15
Sudbury, ON
16
Surrey, BC
17
Surrey, BC
18
Toronto, ON
19
Vancouver, BC
20
Waterloo, ON
21
Westmount, QC
22
Winnipeg, MB
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Study Design

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Single Group Design

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

    • Subjects who have been on Adalimumab monotherapy every other week (EOW) for at least 16 weeks but, who in the opinion of the Investigator, have shown a sub-optimal response to treatment and have a Physician Global Assessment (PGA) of ≥ 3 and a Psoriasis Area and Severity Index (PASI) of ≥ 5; or Subjects who after an initial positive response to Adalimumab monotherapy EOW have a sub-optimal response and have a PGA of ≥ 3 and a PASI of ≥ 5;
    • Subjects who are receiving Adalimumab once weekly must be on Adalimumab EOW for 8 weeks prior to study enrolment;
    • Subjects with at least a 6-month history of chronic plaque Psoriasis;
    • Subject is judged to be in good general health as determined by the principal Investigator based on the results of medical history, laboratory profile, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening;
    • Subjects must be evaluated for latent Tuberculosis (TB) infection with a purified protein derivative (PPD) test, or QuantiFERON-TB test and chest X-ray. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement or a positive QuantiFERON-TB test result.
    • Subject has any contraindications to Methotrexate or Adalimumab;
    • Subject has a previous failed response or poor tolerance to Adalimumab;
    • Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study;
    • Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis);
    • Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease;
    • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

More on this trial

Clinical Trials.gov