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A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL) (CONTROL)

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ClinicalTrials.gov Identifier: NCT02814175
Recruitment Status : Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in subjects with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 is designed to compare the achievement of minimal disease activity (MDA) between subjects randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 is to evaluate the maintenance or achievement of MDA on four different treatment regimens using adalimumab and/or MTX, with subject allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: methotrexate (MTX) Biological: adalimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)
Actual Study Start Date : August 5, 2016
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : March 26, 2020


Arm Intervention/treatment
Active Comparator: Arm 2/Part 1
MTX highest recommended or tolerable dose
Drug: methotrexate (MTX)
Active Comparator: Arm 1/Part 1
adalimumab + MTX low dose
Drug: methotrexate (MTX)
Biological: adalimumab
Active Comparator: Arm 3/Part 2
MTX highest recommended or tolerable dose
Drug: methotrexate (MTX)
Active Comparator: Arm 4/Part 2
adalimumab +MTX highest recommended or tolerable dose
Drug: methotrexate (MTX)
Biological: adalimumab
Active Comparator: Rescue Arm
adalimumab and/or MTX
Drug: methotrexate (MTX)
Biological: adalimumab
Active Comparator: Arm 2/Part 2
adalimumab + MTX low dose
Drug: methotrexate (MTX)
Biological: adalimumab
Active Comparator: Arm 1/Part 2
adalimumab
Biological: adalimumab



Primary Outcome Measures :
  1. The proportion of subjects achieving minimal disease activity [ Time Frame: At week 16 ]
    Minimal disease activity will be determined by tender and swollen joint counts, PASI or body surface area (BSA), Patient's assessment of pain visual analogue scale, Patient's global assessment of disease activity VAS, HAQ-DI, and tender entheseal points assessment.


Secondary Outcome Measures :
  1. Change in DLQI score from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    DLQI is a measure of subject's quality of life related to skin disease.

  2. Change in tender dactylitic digit count from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    Hands and feet bilaterally will be assessed for the presence/absence of dactylitis and associated tenderness.

  3. Change in DAS28-CRP score from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    DAS28 is a weighted measure of disease activity originally developed for RA, but is also used in PsA clinical trials. DAS28 includes tender and swollen joint counts, Patient's global assessment of disease activity, Patient's global assessment of arthritis and acute phase reactant.

  4. Change in PsAID score from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    PsAID is a validated patient self-reported tool to assess the impact of PsA on the patient's life.

  5. Proportion of subjects achieving ACR 20/50/70 response [ Time Frame: At Week 16 ]
    ACR 20/50/70 response rate will be determined based on 20%, 50%, and 70% or greater improvement of Tender Joint Count and Swollen Joint Counts and greater than or equal to 3 of the 5 measures of Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, HAQ-DI, and CRP.

  6. Change in Leeds Enthesitis Index (LEI) from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions.

  7. Proportion of subjects in minimal disease activity in Part 2 of the study [ Time Frame: At week 32 ]
    Minimal disease activity will be determined by tender and swollen joint counts, PASI or body surface area (BSA), Patient's assessment of pain visual analogue scale, Patient's global assessment of disease activity VAS, HAQ-DI, and tender entheseal points assessment.

  8. Change in PASDAS from baseline [ Time Frame: Measured from Day 1 to week 16 ]
    Psoriatic Arthritis Disease Activity Score is a weighted disease activity measure developed specifically for psoriatic arthritis.

  9. Change in SF-36 score from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    SF-36 is a generic measure to assess patient's general health and well-being.

  10. Change in HAQ-DI score from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    The HAQ-DI is a standardized measure of physical function in arthritis.

  11. Proportion of subjects achieving PASI 75/90/100 response among subjects with BSA greater than or equal to 3%. [ Time Frame: At Week 16 ]
    Denotes greater than or equal to 75%/90%/100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis lesional burden based on the amount of body surface area involved and the degree of severity of erythema, induration, and scale, weighted by body part.

  12. Change in DAPSA score from baseline [ Time Frame: Measured from Day 1 to Week 16 ]
    DAPSA is a psoriatic arthritis disease activity measure, calculated by summing swollen and tender joint counts, Patient's assessment of pain, Patients global assessment of disease activity, and CRP.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
  2. Not in MDA at the time of screening
  3. Has 3 or more tender and 3 or more swollen joints
  4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion Criteria:

  1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
  2. History of methotrexate intolerance/toxicity
  3. Medical conditions(s) precluding methotrexate dose increase above 15 mg
  4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814175


  Show 52 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02814175     History of Changes
Other Study ID Numbers: M14-496
2016-000191-21 ( EudraCT Number )
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Psoriatic Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents