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

NCT02196701 | Completed Phase 3 Results

• 1 other identifier: W14-406
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis

Keywords

methotrexate; adalimumab; biologic; psoriasis; Tumor necrosis factor (TNF)-α inhibitor

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 16

• 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.

  Week 16

Secondary Outcomes (17)

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

  Baseline, week 8 and week 24

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

  Baseline, week 8 and week 24

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

  Baseline, weeks 8, 16, and 24

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

  Baseline, weeks 8, 16, and 24

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

  Baseline and Weeks 8, 16, and 24

Study Arms (1)

Adalimumab Plus Methotrexate

EXPERIMENTAL

Participants 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.

Drug: Adalimumab; Drug: Methotrexate

Interventions

Adalimumab DRUG

Administered by subcutaneous injection every other week.

Also known as: Humira

Adalimumab Plus Methotrexate

Methotrexate DRUG

Methotrexate was provided as 2.5 mg tablets for oral administration.

Adalimumab Plus Methotrexate

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Marc-André Raymond, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: August 5, 2014
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: March 19, 2018
• Results First Posted: March 19, 2018

Record last verified: 2018-01