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PsoriasisPhase 3CLEARNCT02196701

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

A Phase 3 study testing Adalimumab and Methotrexate in people with Psoriasis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Psoriasis
What is being tested?
Adalimumab and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
5 Aug 2014to 17 Mar 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who have been on ADA monotherapy (40 mg eow or greater) 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's Global Assessment (PGA) of ≥ 3 and a Psoriasis Area Severity Index (PASI) of ≥ 5; or Subjects who after an initial positive response to ADA monotherapy (40 mg eow or greater) have failed to maintain an optimal level of response, based on the opinion of the Investigator, and have a PGA of ≥ 3 and a PASI of ≥ 5;
  • Subjects who are receiving 40 mg ADA once weekly must be on ADA 40 mg eow for 8 weeks prior to screening;
  • Subjects with at least a 6 month history of chronic plaque psoriasis;
  • Subjects greater than or equal to 18 years of age;
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile or is of childbearing potential and is practicing birth control;
  • The results of the serum pregnancy test performed during the Screening Period and urine pregnancy test performed at the Baseline Visit must be negative;
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  • Subject is judged to be in good general health as determined by the Principal Investigator;
  • Subjects must be evaluated for latent tuberculosis (TB) infection;
  • Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
  • Subjects must be willing and able to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.

Who cannot join

  • Subject has any contraindications to MTX or ADA;
  • Subject has a previous failed response or poor tolerance to ADA;
  • Subject has a poorly controlled medical 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, renal or liver disease;
  • Subject has a history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease;
  • Subject has evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix;
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  • Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (iv) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit;
  • Subject is known to have immune deficiency, history of human immunodeficiency virus (HIV) or is immunocompromised;
  • Subject currently uses or plans to use anti-retroviral therapy at any time during the study;
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication;
  • Subject has a history of clinically significant drug or alcohol usage in the last year or cannot maintain an alcohol intake of 30 g a day or less throughout the study (one standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine, 360 mL/12 oz (approx. 15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of spirits;
  • Screening clinical laboratory analyses show any of the following abnormal laboratory results:
  • Aspartate transaminase (AST) or alanine transaminase (ALT) > 2x the upper limit of normal (ULN);
  • Serum total bilirubin > 1.5 mg/dL (> 26 micromol/L), except for subjects with Gilbert's Syndrome;
  • Creatinine > 1.5 mg/dL (133 micromol/L) in subjects ≤ 65 years old and > upper limit of normal range in subjects > 65;
  • Positive Hepatitis B or C serology indicative of previous or current infection.
  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study;
  • The following treatments are prohibited for all subjects during the study:
  • Phototherapy (ultraviolet A with psoralen [PUVA] within 4 weeks of the Baseline Visit and/or ultraviolet B (UVB) within 2 weeks of the Baseline Visit);
  • Other biologic therapies (including any other anti-tumor necrosis factor [TNF]) within 4 weeks of the Baseline Visit;
  • Any investigational agents of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Baseline visit ;
  • Any other systemic drug therapies for psoriasis within 4 weeks of the Baseline Visit;
  • Oral or injectable corticosteroids, new prescription topical therapies, or changes in the concentration of current prescription topical therapies (including corticosteroids) that are being used, within 2 weeks of the Baseline Visit. Subjects may continue using previously prescribed topical therapies (including corticosteroids) during the study.
  • Prior exposure to biologics that have a potential or known association with progressive multifocal leukoencephalopathy (PML), i.e., natalizumab (Tysabri®) or rituximab (Rituxan®);
  • Subjects with any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study;

About this study

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.

Conditions
Psoriasis
Keywords
methotrexate, adalimumab, biologic, psoriasis, Tumor necrosis factor (TNF)-α inhibitor
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    Also called Humira

    Administered by subcutaneous injection every other week.

  • MethotrexateDrug

    Methotrexate was provided as 2.5 mg tablets for oral administration.

Study groups in NCT02196701
Study groupRoleWhat they receive
Adalimumab Plus MethotrexateExperimentalParticipants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Receives: Drug: Adalimumab; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment

    Study investigators were asked to complete the following questionnaire at week 16:

    Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:

    • Completely dissatisfied
    • Moderately dissatisfied
    • Slightly satisfied
    • Highly satisfied
    • Completely satisfied

    Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

    Measured: Week 16

  2. Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment

    Participants were asked to complete the following questionnaire at week 16:

    Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:

    • Completely dissatisfied
    • Moderately dissatisfied
    • Slightly satisfied
    • Highly satisfied
    • Completely satisfied

    Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

    Measured: Week 16

Secondary outcomes (17)

  1. Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time

    Study investigators were asked to complete the following questionnaire at each scheduled visit:

    Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:

    • Completely dissatisfied
    • Moderately dissatisfied
    • Slightly satisfied
    • Highly satisfied
    • Completely satisfied

    Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

    Measured: Baseline, week 8 and week 24

  2. Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time

    Participants were asked to complete the following questionnaire at each scheduled visit:

    Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:

    • Completely dissatisfied
    • Moderately dissatisfied
    • Slightly satisfied
    • Highly satisfied
    • Completely satisfied

    Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

    Measured: Baseline, week 8 and week 24

  3. Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time

    Study investigators were asked to complete the following questionnaire at each scheduled visit:

    Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:

    • Completely dissatisfied
    • Moderately dissatisfied
    • Slightly satisfied
    • Highly satisfied
    • Completely satisfied

    Measured: Baseline, weeks 8, 16, and 24

  4. Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time

    Participants were asked to complete the following questionnaire at each scheduled visit:

    Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:

    • Completely dissatisfied
    • Moderately dissatisfied
    • Slightly satisfied
    • Highly satisfied
    • Completely satisfied

    Measured: Baseline, weeks 8, 16, and 24

  5. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.

    Measured: Baseline and Weeks 8, 16, and 24

  6. Percentage of Participants Who Achieved a PASI 75 Response Over Time

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.

    Measured: Baseline and Weeks 8, 16, and 24

  7. Percentage of Participants Who Achieved a PASI 90 Response Over Time

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.

    Measured: Baseline and Weeks 8, 16, and 24

  8. Percentage of Participants Who Achieved a PASI 100 Response Over Time

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.

    Measured: Baseline and Weeks 8, 16, and 24

  9. Change From Baseline in PASI Score Over Time

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

    Measured: Baseline and weeks 8, 16, and 24

  10. Percent Change From Baseline in PASI Score

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

    Measured: Baseline and weeks 8, 16, and 24

  11. Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time

    The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Cleared): No evidence of scaling, erythema, or plaque elevation;
    • 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;
    • 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;
    • 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;
    • 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;
    • 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.

    The percentage of participants achieving a score of clear (0) or minimal (1) is reported.

    Measured: Weeks 8, 16, and 24

  12. Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis

    The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.

    A decrease in BSA affected by psoriasis indicates improvement.

    Measured: Baseline and weeks 8, 16, and 24

  13. Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis

    The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.

    A decrease in BSA affected by psoriasis indicates improvement.

    Measured: Baseline and weeks 8, 16, and 24

  14. Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time

    The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.

    Measured: Baseline, weeks 8, 16, and 24

  15. Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time

    The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.

    Measured: Baseline, weeks 8, 16, and 24

  16. Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time

    The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.

    Measured: Baseline and Weeks 8, 16, and 24

  17. Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24

    Measured: Baseline and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2014 (estimated)
  2. Study start5 Aug 2014
  3. Primary completion17 Mar 2017
  4. Study completion17 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02196701
Sponsor's protocol ID
W14-406
Acronym
CLEAR
Status last verified
Jan 2018
First submitted
18 Jul 2014
Last updated
19 Mar 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab and Methotrexate in people with Psoriasis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02196701.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.

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