Back to results

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

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

methotrexate (MTX)

adalimumab (ADA)

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

AZ Arthritis & Rheum Research /ID# 161796
LeJenue Research Associates /ID# 200093
Deerbrook Medical Associates /ID# 158655
Ochsner Clinic Foundation /ID# 155178
Clinical Pharmacology Study Gr /ID# 161057
Shores Rheumatology, PC /ID# 162697
Coastal Carolina Health Care /ID# 152088
PMG Research of Wilmington LLC /ID# 152089
Altoona Ctr Clinical Res /ID# 152087
Metroplex Clinical Research /ID# 162486
Swedish Medical Center /ID# 162051
West Virginia Research Inst /ID# 157815
Royal Prince Alfred Hospital /ID# 153144
Optimus Clinical Research Pty. /ID# 153145
Liverpool Hospital /ID# 153147
BJC Health /ID# 153875
Box Hill Hospital /ID# 153146
Hospital de Clinicas de Porto Alegre /ID# 152345
Faculdade de Medicina do ABC /ID# 152344
MHAT Trimontsium /ID# 152658
Diag Consult Ctr 17 Sofia EOOD /ID# 152657
Rheumatology Research Assoc /ID# 161600
Percuro Clinical Research, Ltd /ID# 161601
Manitoba Clinic /ID# 151939
St. Clare's Mercy Hospital /ID# 159680
The Waterside Clinic /ID# 151938
Adachi Medicine Prof. Corp /ID# 152575
Ctr. de Rheum de l'est du QC /ID# 151937
Groupe de Recherche en Maladies Osseuses /ID# 205693
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 151954
Riesgo de Fractura S.A - CAYRE /ID# 153817
San Vicente Fundacion /Id# 171324
Revmatolog s.r.o. /ID# 151753
Nuselská poliklinika, Revmatologie /ID# 151754
Universitaetsklinik Heidelberg /ID# 152229
Fachpraxis fuer Rheumatologie und Osteologie /ID# 203982
Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 152231
CIRI GmbH /ID# 152228
Hamburger Rheuma I /ID# 164055
Universita di Catanzaro Magna Graecia /ID# 152013
Azienda Ospedaliera Policlinic /ID# 152011
A.O. Universitaria Senese /ID# 152012
McBk Sc /Id# 163089
Centrum Medyczne AMED /ID# 164047
SANUS Szpital Specjalistyczny /ID# 151988
ClinicMed Badurski i wspolnicy SJ /ID# 151987
Dr. Ramon L. Ortega-Colon, MD /ID# 152957
GCM Medical Group, PSC /ID# 152091
Hamad Hospital /ID# 152334
Corporac Sanitaria Parc Tauli /ID# 151759
Hospital Univ Germans Trias I Pujol /ID# 151760
Hospital Universitario Reina S /ID# 151761
Hospital Manises /ID# 162778
Hospital Univ Canarias /ID# 206489
Hospital de Viladecans /ID# 163875
Royal National Hosp for Rheuma /ID# 152767
Western General Hospital /ID# 155195
Altnagelvin Area Hospital /ID# 152766
Central Manchester University /ID# 152765
Lancashire Care NHS Foundation /ID# 152769

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Part 1: MTX Escalated Dose

Part 1: ADA + MTX

Part 2: MTX Escalated Dose

Part 2: ADA + MTX Escalated Dose

Part 2: ADA

Part 2: ADA ew + MTX

Arm Description

Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)

Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)

Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment Questionnaire Disability Index (HAQ-DI) score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).

Secondary Outcome Measures

Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)

The Dermatology Life Quality Index (DLQI) score is a measure of participant's quality of life (QOL) related to skin disease.The DLQI questionnaire consists of 10 questions concerning participants' perception of the impact of skin diseases on different aspects of their health related QOL over the last week. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. The range of possible DLQI scores is 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.

Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)

Hands and feet bilaterally were assessed for the presence/absence of dactylitis and associated tenderness for participants with presence of dactylitis at baseline. The tender dactylitic digit count is equal to the number of swollen and painful digits (range 0 to 20). A decrease indicates improvement.

Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)

The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity but is also used in PsA clinical trials. DAS28 is a composite score calculated using a mathematical formula based on the scores for these scales. DAS28 includes tender and swollen joint counts, PtGA, and acute phase reactant (CRP in this study). DAS28 scores range from 0 to 10, with higher scores indicating more disease activity. A larger negative change in the DAS28 score indicates greater improvement.

Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)

Psoriatic Arthritis Impact of Disease Score (PsAID) was developed by an European League Against Rheumatism (EULAR) initiative and is a validated patient self-reported tool to assess the impact of PsA on the participant's life. The PsAID is a composite score calculated using a mathematical formula based on the scores for each component. PsAID-9 was developed for clinical trials and was used in this study. The PsAID-9 is calculated based on 9 Numerical rating scales (NRS) questions that include pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, and anxiety). Each NRS is assessed as a number between 0 and 10. PsAID scores range from 0 to 10, with higher scores indicating worse status. A larger negative change in the PsAID-9 score indicates greater improvement.

Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)

The ACR is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for RA, but is also widely used in PsA. The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI) and acute phase reactant (using CRP). ACR 20/50/70 response is achieved if ≥ 20%/≥ 50%/≥ 70% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a ≥ 20%/≥ 50%/≥ 70% improvement in ≥ 3 of the other 5 parameters.

Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline

The Leeds Enthesitis Index (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 for participants with presence of LEI at baseline.Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A decrease in LEI indicates improvement.

Percentage of Participants in MDA in Part 2 of the Study (Week 32)

MDA for PsA was defined as fulfilling at least 5 of the following 7 criteria: TJC ≤ 1 (out of TJC68 assessed in this study), SJC ≤ 1 (out of SJC66 assessed in this study), PASI ≤ 1 or BSA ≤ 3; Patient's assessment of pain VAS ≤ 15, PtGA VAS ≤ 20, HAQ-DI score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).

Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)

Psoriatic Arthritis Disease Activity Score (PASDAS) is a weighted disease activity measure developed specifically for PsA. It includes PhGA, PtGA, SF-36 PCS, SJC, TJC, Leeds enthesitis count, tender dactylitic count and hsCRP lab test. The PASDAS is a composite score calculated using a mathematical formula based on the scores for each component. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement. .

Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1)

The Short Form Health Survey 36 (SF-36) is a generic measure to assess participant's general health/well-being (health related quality of life); short version 2 (SF-36v2) was used. SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise physical component of the SF-36. Scores on each item were summed and averaged (PCS; range = 0-100). Items 5-8 comprise mental component of the SF-36. Scores on each item were summed and averaged (mental component score [MCS]; range = 0-100). Larger values on SF-36 indicate a better condition. A positive change from Baseline in either PCS or MCS indicates improvement.

Change in HAQ-DI Score From Baseline (Part 1)

The HAQ-DI is a standardized measure of physical function in arthritis. The HAQ-DI questionnaire contains 20 items divided into 8 domains that measure: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement.

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)

Psoriasis Area and Severity Index (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. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. 75/90/100 denotes greater than or equal to 75%/90%/100% improvement in PASI score. A 100% reduction is considered complete clearance of psoriasis.

Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)

Disease Activity in Psoriatic Arthritis Score (DAPSA) score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 100 centimeter [cm] VAS, 0=excellent and 10=poor). Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity.

Full Information

NCT ID

NCT02814175

First Posted

June 21, 2016

Last Updated

October 30, 2020

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02814175

Brief Title

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

Acronym

CONTROL

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

August 5, 2016 (Actual)

Primary Completion Date

September 23, 2019 (Actual)

Study Completion Date

March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: MTX Escalated Dose

Arm Type

Active Comparator

Arm Description

Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)

Arm Title

Part 1: ADA + MTX

Arm Type

Experimental

Arm Description

Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew

Arm Title

Part 2: MTX Escalated Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Part 2: ADA + MTX Escalated Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Part 2: ADA

Arm Type

Experimental

Arm Description

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

Arm Title

Part 2: ADA ew + MTX

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

methotrexate (MTX)

Intervention Type

Biological

Intervention Name(s)

adalimumab (ADA)

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

Title

Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

Title

Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

Title

Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

Title

Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)

Description

Time Frame

Week 16

Title

Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline

Description

Time Frame

From Day 1 to Week 16

Title

Percentage of Participants in MDA in Part 2 of the Study (Week 32)

Description

Time Frame

Week 32

Title

Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)

Description

Time Frame

From Day 1 to week 16

Title

Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

Title

Change in HAQ-DI Score From Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

Title

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)

Description

Time Frame

Week 16

Title

Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)

Description

Time Frame

From Day 1 to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria Not in MDA at the time of screening Has 3 or more tender and 3 or more swollen joints Treated with methotrexate 15 mg (weekly) for at least 4 weeks Exclusion Criteria: Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients History of methotrexate intolerance/toxicity Medical conditions(s) precluding methotrexate dose increase above 15 mg Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

AZ Arthritis & Rheum Research /ID# 161796

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

LeJenue Research Associates /ID# 200093

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Deerbrook Medical Associates /ID# 158655

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

Ochsner Clinic Foundation /ID# 155178

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70836-6455

Country

United States

Facility Name

Clinical Pharmacology Study Gr /ID# 161057

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Shores Rheumatology, PC /ID# 162697

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Coastal Carolina Health Care /ID# 152088

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

PMG Research of Wilmington LLC /ID# 152089

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Altoona Ctr Clinical Res /ID# 152087

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Metroplex Clinical Research /ID# 162486

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Swedish Medical Center /ID# 162051

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

West Virginia Research Inst /ID# 157815

City

South Charleston

State/Province

West Virginia

ZIP/Postal Code

25309

Country

United States

Facility Name

Royal Prince Alfred Hospital /ID# 153144

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Optimus Clinical Research Pty. /ID# 153145

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Liverpool Hospital /ID# 153147

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

BJC Health /ID# 153875

City

Paramatta

State/Province

New South Wales

ZIP/Postal Code

2150

Country

Australia

Facility Name

Box Hill Hospital /ID# 153146

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Hospital de Clinicas de Porto Alegre /ID# 152345

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Faculdade de Medicina do ABC /ID# 152344

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09060-870

Country

Brazil

Facility Name

MHAT Trimontsium /ID# 152658

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Diag Consult Ctr 17 Sofia EOOD /ID# 152657

City

Sofia

ZIP/Postal Code

1505

Country

Bulgaria

Facility Name

Rheumatology Research Assoc /ID# 161600

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5M 0H4

Country

Canada

Facility Name

Percuro Clinical Research, Ltd /ID# 161601

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

Manitoba Clinic /ID# 151939

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

St. Clare's Mercy Hospital /ID# 159680

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 5B8

Country

Canada

Facility Name

The Waterside Clinic /ID# 151938

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Adachi Medicine Prof. Corp /ID# 152575

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Ctr. de Rheum de l'est du QC /ID# 151937

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 8W1

Country

Canada

Facility Name

Groupe de Recherche en Maladies Osseuses /ID# 205693

City

Sainte-foy

State/Province

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 151954

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Riesgo de Fractura S.A - CAYRE /ID# 153817

City

Bogota

ZIP/Postal Code

111121

Country

Colombia

Facility Name

San Vicente Fundacion /Id# 171324

City

Medellin

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Revmatolog s.r.o. /ID# 151753

City

Jihlava 1

State/Province

Jihlava

ZIP/Postal Code

586 01

Country

Czechia

Facility Name

Nuselská poliklinika, Revmatologie /ID# 151754

City

Prague 4

State/Province

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Universitaetsklinik Heidelberg /ID# 152229

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Fachpraxis fuer Rheumatologie und Osteologie /ID# 203982

City

Bruchhausen-Vilsen

State/Province

Niedersachsen

ZIP/Postal Code

27305

Country

Germany

Facility Name

Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 152231

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

CIRI GmbH /ID# 152228

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Hamburger Rheuma I /ID# 164055

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Universita di Catanzaro Magna Graecia /ID# 152013

City

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

Azienda Ospedaliera Policlinic /ID# 152011

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

A.O. Universitaria Senese /ID# 152012

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

McBk Sc /Id# 163089

City

Grodzisk Mazowiecki

State/Province

Mazowieckie

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Centrum Medyczne AMED /ID# 164047

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

01-518

Country

Poland

Facility Name

SANUS Szpital Specjalistyczny /ID# 151988

City

Stalowa Wola

State/Province

Podkarpackie

ZIP/Postal Code

37-450

Country

Poland

Facility Name

ClinicMed Badurski i wspolnicy SJ /ID# 151987

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Dr. Ramon L. Ortega-Colon, MD /ID# 152957

City

Carolina

ZIP/Postal Code

00983

Country

Puerto Rico

Facility Name

GCM Medical Group, PSC /ID# 152091

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

Hamad Hospital /ID# 152334

City

Doha

State/Province

Ad Dawhah

Country

Qatar

Facility Name

Corporac Sanitaria Parc Tauli /ID# 151759

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Univ Germans Trias I Pujol /ID# 151760

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitario Reina S /ID# 151761

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Manises /ID# 162778

City

Manises

ZIP/Postal Code

46940

Country

Spain

Facility Name

Hospital Univ Canarias /ID# 206489

City

Santa Cruz de Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Hospital de Viladecans /ID# 163875

City

Viladecans

ZIP/Postal Code

8840

Country

Spain

Facility Name

Royal National Hosp for Rheuma /ID# 152767

City

Bath

ZIP/Postal Code

BA1 1RL

Country

United Kingdom

Facility Name

Western General Hospital /ID# 155195

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Altnagelvin Area Hospital /ID# 152766

City

Londonderry

ZIP/Postal Code

BT47 6SB

Country

United Kingdom

Facility Name

Central Manchester University /ID# 152765

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Lancashire Care NHS Foundation /ID# 152769

City

Preston

ZIP/Postal Code

BT47 3EN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Learn more about this trial

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

We'll reach out to this number within 24 hrs