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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02814175




Registration number
NCT02814175
Ethics application status
Date submitted
21/06/2016
Date registered
27/06/2016

Titles & IDs
Public title
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Scientific 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)
Secondary ID [1] 0 0
2016-000191-21
Secondary ID [2] 0 0
M14-496
Universal Trial Number (UTN)
Trial acronym
CONTROL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Part 1: MTX Escalated Dose - Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)

Experimental: Part 1: ADA + MTX - Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew

Active comparator: Part 2: MTX Escalated Dose - Participants achieving minimal disease activity (MDA) at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose

Active comparator: Part 2: ADA + MTX Escalated Dose - Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew

Experimental: Part 2: ADA - Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy

Experimental: Part 2: ADA ew + MTX - Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)
Timepoint [1] 0 0
From Day 1 to Week 16
Secondary outcome [2] 0 0
Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)
Timepoint [2] 0 0
From Day 1 to Week 16
Secondary outcome [3] 0 0
Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)
Timepoint [3] 0 0
From Day 1 to Week 16
Secondary outcome [4] 0 0
Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)
Timepoint [4] 0 0
From Day 1 to Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline
Timepoint [6] 0 0
From Day 1 to Week 16
Secondary outcome [7] 0 0
Percentage of Participants in MDA in Part 2 of the Study (Week 32)
Timepoint [7] 0 0
Week 32
Secondary outcome [8] 0 0
Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)
Timepoint [8] 0 0
From Day 1 to week 16
Secondary outcome [9] 0 0
Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1)
Timepoint [9] 0 0
From Day 1 to Week 16
Secondary outcome [10] 0 0
Change in HAQ-DI Score From Baseline (Part 1)
Timepoint [10] 0 0
From Day 1 to Week 16
Secondary outcome [11] 0 0
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1)
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)
Timepoint [12] 0 0
From Day 1 to Week 16

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2020
Sample size
Target
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 153144 - Camperdown
Recruitment hospital [2] 0 0
Optimus Clinical Research Pty. /ID# 153145 - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital /ID# 153147 - Liverpool
Recruitment hospital [4] 0 0
BJC Health /ID# 153875 - Paramatta
Recruitment hospital [5] 0 0
Box Hill Hospital /ID# 153146 - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2150 - Paramatta
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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Florida
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Illinois
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Louisiana
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Massachusetts
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Michigan
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North Carolina
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Pennsylvania
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Texas
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Washington
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United States of America
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West Virginia
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
Country [14] 0 0
Bulgaria
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Plovdiv
Country [15] 0 0
Bulgaria
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Sofia
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Canada
State/province [16] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Colombia
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Cundinamarca
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Colombia
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Bogota
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Colombia
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Medellin
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Czechia
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Jihlava
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Czechia
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Praha 4
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Germany
State/province [27] 0 0
Baden-Wuerttemberg
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Germany
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Niedersachsen
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Germany
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Schleswig-Holstein
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Germany
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Frankfurt
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Germany
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Hamburg
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Italy
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Calabria
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Italy
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Rome
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Italy
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Siena
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Poland
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Mazowieckie
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Podkarpackie
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Bialystok
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Carolina
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San Juan
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Qatar
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Ad Dawhah
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Barcelona
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Badalona
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Cordoba
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Manises
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Spain
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Santa Cruz de Tenerife
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Spain
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Viladecans
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United Kingdom
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Bath
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United Kingdom
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Edinburgh
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United Kingdom
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Londonderry
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United Kingdom
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Manchester
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United Kingdom
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Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02814175