Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis

NCT00420927 | Completed Phase 4 Results

• 2 other identifiers: M06-8102006-004139-31
• Study Type: interventional
• Target: 1,032
• Locations: 20 countries
• Sites: 164

Brief Summary

This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).

Conditions

Rheumatoid Arthritis

Keywords

Early Rheumatoid Arthritis; Tumor Necrosis Factor Optimization

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4

  The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.

  Week 78

Secondary Outcomes (18)

• Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1

  Week 78

• Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78

  Week 78

• Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78

  Week 78

• Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78

  Week 78

• Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78

  Week 78

Study Arms (5)

ADA+MTX/PBO+MTX (Arm 1)

EXPERIMENTAL

Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2

Biological: adalimumab; Drug: methotrexate; Biological: placebo

ADA+MTX/ADA+MTX (Arm2)

EXPERIMENTAL

Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2

Biological: adalimumab; Drug: methotrexate

ADA+MTX/OL ADA+MTX (Arm 3)

EXPERIMENTAL

Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA + MTX during Period 2

Biological: adalimumab; Drug: methotrexate

PBO+MTX/PBO+MTX (Arm 4)

EXPERIMENTAL

Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2

Drug: methotrexate; Biological: placebo

PBO+MTX/OL ADA+MTX (Arm 5)

EXPERIMENTAL

Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2.

Biological: adalimumab; Drug: methotrexate; Biological: placebo

Interventions

adalimumab BIOLOGICAL

Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

Also known as: Humira, D2E7

ADA+MTX/ADA+MTX (Arm2); ADA+MTX/OL ADA+MTX (Arm 3); ADA+MTX/PBO+MTX (Arm 1); PBO+MTX/OL ADA+MTX (Arm 5)

methotrexate DRUG

Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.

ADA+MTX/ADA+MTX (Arm2); ADA+MTX/OL ADA+MTX (Arm 3); ADA+MTX/PBO+MTX (Arm 1); PBO+MTX/OL ADA+MTX (Arm 5); PBO+MTX/PBO+MTX (Arm 4)

placebo BIOLOGICAL

Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

ADA+MTX/PBO+MTX (Arm 1); PBO+MTX/OL ADA+MTX (Arm 5); PBO+MTX/PBO+MTX (Arm 4)

Eligibility Criteria

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

You may qualify if:

• Subject must be 18 or older and in good health
• Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis
• Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
• Subject must fulfill at least one of the following three criteria:
• Rheumatoid factor positive
• Greater than 1 joint erosion
• Anti-cyclic citrullinated peptide (CCP) antibody positive.

You may not qualify if:

• Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
• Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline
• Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.

Sponsors & Collaborators

• Abbott: lead

Study Sites (170)

Site Reference ID/Investigator# 4560

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 4547

Birmingham, Alabama, 35294-7201, United States

Location

Site Reference ID/Investigator# 6222

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 4537

Mobile, Alabama, 36608, United States

Location

Site Reference ID/Investigator# 6758

Tuscaloosa, Alabama, 35406, United States

Location

Site Reference ID/Investigator# 9323

Hemet, California, 92543, United States

Location

Site Reference ID/Investigator# 4568

La Jolla, California, 92037-0943, United States

Location

Site Reference ID/Investigator# 4535

Palm Desert, California, 92260, United States

Location

Site Reference ID/Investigator# 4571

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 9271

Torrance, California, 90505, United States

Location

Site Reference ID/Investigator# 10746

Victorville, California, 92395, United States

Location

Site Reference ID/Investigator# 4559

Denver, Colorado, 80230, United States

Location

Site Reference ID/Investigator# 6229

Aventura, Florida, 33180, United States

Location

Site Reference ID/Investigator# 10603

Lake Mary, Florida, 32746, United States

Location

Site Reference ID/Investigator# 9325

Orange Park, Florida, 32073, United States

Location

Site Reference ID/Investigator# 4550

Palm Harbor, Florida, 34684, United States

Location

Site Reference ID/Investigator# 4570

Sarasota, Florida, 34239, United States

Location

Site Reference ID/Investigator# 4601

Tampa, Florida, 33614, United States

Location

Site Reference ID/Investigator# 4552

Vero Beach, Florida, 32960, United States

Location

Site Reference ID/Investigator# 10745

Meridian, Idaho, 83642, United States

Location

Site Reference ID/Investigator# 4548

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 4557

Springfield, Illinois, 62704, United States

Location

Site Reference ID/Investigator# 4605

Wichita, Kansas, 67203, United States

Location

Site Reference ID/Investigator# 10741

Wheaton, Maryland, 20902, United States

Location

Site Reference ID/Investigator# 6417

Fall River, Massachusetts, 02720, United States

Location

Site Reference ID/Investigator# 4561

Dover, New Hampshire, 03820, United States

Location

Site Reference ID/Investigator# 11222

Freehold, New Jersey, 07728, United States

Location

Site Reference ID/Investigator# 6228

Passaic, New Jersey, 07055, United States

Location

Site Reference ID/Investigator# 4544

Albuquerque, New Mexico, 87102, United States

Location

Site Reference ID/Investigator# 4534

Orchard Park, New York, 14127, United States

Location

Site Reference ID/Investigator# 9324

Plainview, New York, 11803, United States

Location

Site Reference ID/Investigator# 4600

Smithtown, New York, 11787, United States

Location

Site Reference ID/Investigator# 12821

The Bronx, New York, 10461, United States

Location

Site Reference ID/Investigator# 4549

Mayfield Village, Ohio, 44143, United States

Location

Site Reference ID/Investigator# 6227

Bend, Oregon, 97701, United States

Location

Site Reference ID/Investigator# 4546

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 4564

West Reading, Pennsylvania, 19611-1124, United States

Location

Site Reference ID/Investigator# 4558

Wexford, Pennsylvania, 15090, United States

Location

Site Reference ID/Investigator# 4533

Charleston, South Carolina, 29406, United States

Location

Site Reference ID/Investigator# 7482

Greenville, South Carolina, 29601, United States

Location

Site Reference ID/Investigator# 10743

Jackson, Tennessee, 38305, United States

Location

Site Reference ID/Investigator# 4562

Nashville, Tennessee, 37205, United States

Location

Site Reference ID/Investigator# 4536

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 4538

Houston, Texas, 77074, United States

Location

Site Reference ID/Investigator# 6899

San Antonio, Texas, 78217, United States

Location

Site Reference ID/Investigator# 6381

Tyler, Texas, 75701, United States

Location

Site Reference ID/Investigator# 10744

Seattle, Washington, 98133, United States

Location

Site Reference ID/Investigator# 4545

Glendale, Wisconsin, 53217, United States

Location

Site Reference ID/Investigator# 4572

Oak Creek, Wisconsin, 53154, United States

Location

Site Reference ID/Investigator# 3886

Buenos Aires, 1426AAL, Argentina

Location

Site Reference ID/Investigator# 3888

Buenos Aires, C1015ABO, Argentina

Location

Site Reference ID/Investigator# 6346

Buenos Aires, C1055AAF, Argentina

Location

Site Reference ID/Investigator# 3887

Quilmes, Argentina

Location

Site Reference ID/Investigator# 3889

San Miguel de Tucumán, T4000AXL, Argentina

Location

Site Reference ID/Investigator# 8380

Campsie, Sydney, 2194, Australia

Location

Site Reference ID/Investigator# 6954

Clayton, 3168, Australia

Location

Site Reference ID/Investigator# 6940

Malvern East, 3145, Australia

Location

Site Reference ID/Investigator# 3915

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 3911

Graz, A-8020, Austria

Location

Site Reference ID/Investigator# 3880

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 3885

Vienna, 1100, Austria

Location

Site Reference ID/Investigator# 3916

Vienna, 1130, Austria

Location

Site Reference ID/Investigator# 7792

Vienna, 1160, Austria

Location

Site Reference ID/Investigator# 3914

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 3909

Genk, 3600, Belgium

Location

Site Reference ID/Investigator# 3881

Gilly, 6060, Belgium

Location

Site Reference ID/Investigator# 3376

Liège, 4000, Belgium

Location

Site Reference ID/Investigator# 6720

Mechelen, 2800, Belgium

Location

Site Reference ID/Investigator# 6718

Sint-Niklaas, 9100, Belgium

Location

Site Reference ID/Investigator# 3910

Yvoir, 5530, Belgium

Location

Site Reference ID/Investigator# 6701

Burlington, L7R 1E2, Canada

Location

Site Reference ID/Investigator# 6834

Edmonton, T5M 0H4, Canada

Location

Site Reference ID/Investigator# 7197

Halifax, B3H 4K4, Canada

Location

Site Reference ID/Investigator# 3883

Hamilton, L8N 1Y2, Canada

Location

Site Reference ID/Investigator# 3884

Hamilton, L8N 2B6, Canada

Location

Site Reference ID/Investigator# 3907

Montreal, H2L 1S6, Canada

Location

Site Reference ID/Investigator# 3903

Montreal, H3Z 2Z3, Canada

Location

Site Reference ID/Investigator# 5178

Ottawa, K2G 6E2, Canada

Location

Site Reference ID/Investigator# 3904

Richmond, V7C 5L9, Canada

Location

Site Reference ID/Investigator# 3912

Sainte-Foy, Quebec, G1W 4R4, Canada

Location

Site Reference ID/Investigator# 3901

Sarnia, N7T 5W6, Canada

Location

Site Reference ID/Investigator# 3906

St. John's, A1A 5E8, Canada

Location

Site Reference ID/Investigator# 6542

Toronto, M9B 1B1, Canada

Location

Site Reference ID/Investigator# 3882

Victoria, V8V 3P9, Canada

Location

Site Reference ID/Investigator# 5616

Windsor, N8X 5A6, Canada

Location

Site Reference ID/Investigator# 5847

Winnipeg, R3A 1M3, Canada

Location

Site Reference ID/Investigator# 3905

Winnipeg, R3A 1M4, Canada

Location

Site Reference ID/Investigator# 3968

Brno, 65691, Czechia

Location

Site Reference ID/Investigator# 3971

Hradec Králové, 500 05, Czechia

Location

Site Reference ID/Investigator# 5559

Ostrava, 72200, Czechia

Location

Site Reference ID/Investigator# 3969

Prague, 128 50, Czechia

Location

Site Reference ID/Investigator# 5548

Uherské Hradiště, 686 01, Czechia

Location

Site Reference ID/Investigator# 3982

Amiens, 80054, France

Location

Site Reference ID/Investigator# 3979

Le Mans, 72037, France

Location

Site Reference ID/Investigator# 3983

Paris, 75679, France

Location

Site Reference ID/Investigator# 3918

Strasbourg, 67098, France

Location

Site Reference ID/Investigator# 3926

Bad Nauheim, D-61231, Germany

Location

Site Reference ID/Investigator# 3928

Buch, 13125, Germany

Location

Site Reference ID/Investigator# 3978

Damp, 24351, Germany

Location

Site Reference ID/Investigator# 3924

Düsseldorf, 40225, Germany

Location

Site Reference ID/Investigator# 3965

Frankfurt, 60590, Germany

Location

Site Reference ID/Investigator# 3927

Frankfurt am Main, 60596, Germany

Location

Site Reference ID/Investigator# 3925

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 4291

Halle, 06120, Germany

Location

Site Reference ID/Investigator# 8489

Hofheim, D-65719, Germany

Location

Site Reference ID/Investigator# 3923

Munich, 80336, Germany

Location

Site Reference ID/Investigator# 8483

Osnabrück, D-49074, Germany

Location

Site Reference ID/Investigator# 8486

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 3919

Vogelsang-Gommern, 39245, Germany

Location

Site Reference ID/Investigator# 6637

Zerbst, 39261, Germany

Location

Site Reference ID/Investigator# 3921

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 3922

Budapest, 1277, Hungary

Location

Site Reference ID/Investigator# 3920

Debrecen, 4012, Hungary

Location

Site Reference ID/Investigator# 3824

Aguascallentes, 20230, Mexico

Location

Site Reference ID/Investigator# 3822

León, 37000, Mexico

Location

Site Reference ID/Investigator# 3825

Mexico City, 10700, Mexico

Location

Site Reference ID/Investigator# 3951

Mexico City, 10700, Mexico

Location

Site Reference ID/Investigator# 3890

Mexico City, 14389, Mexico

Location

Site Reference ID/Investigator# 3823

Mexico City, CP 1300, Mexico

Location

Site Reference ID/Investigator# 3891

Mexico City, CP 14050, Mexico

Location

Site Reference ID/Investigator# 3947

Arnhem, 6815 AD, Netherlands

Location

Site Reference ID/Investigator# 3948

Hilversum, 1213XZ, Netherlands

Location

Site Reference ID/Investigator# 8485

Auckland, New Zealand

Location

Site Reference ID/Investigator# 8488

Hamilton, New Zealand

Location

Site Reference ID/Investigator# 8496

Timaru, New Zealand

Location

Site Reference ID/Investigator# 8511

Wellington, New Zealand

Location

Site Reference ID/Investigator# 7607

Ålesund, N-6026, Norway

Location

Site Reference ID/Investigator# 7935

Kristiansand, 4615, Norway

Location

Site Reference ID/Investigator# 7506

Levanger, 7600, Norway

Location

Site Reference ID/Investigator# 7511

Lillehammer, N-2609, Norway

Location

Site Reference ID/Investigator# 7500

Trondheim, N-7006, Norway

Location

Site Reference ID/Investigator# 3963

Bydgoszcz, 85168, Poland

Location

Site Reference ID/Investigator# 3962

Katowice, 40635, Poland

Location

Site Reference ID/Investigator# 5560

Lublin, 20954, Poland

Location

Site Reference ID/Investigator# 3961

Wroclaw, 53-342, Poland

Location

Site Reference ID/Investigator# 3944

Caguas, 00725, Puerto Rico

Location

Site Reference ID/Investigator# 3937

Ponce, 00716, Puerto Rico

Location

Site Reference ID/Investigator# 3934

San Juan, 00918, Puerto Rico

Location

Site Reference ID/Investigator# 3935

San Juan, 00936-5067, Puerto Rico

Location

Site Reference ID/Investigator# 3959

Piešťany, 92112, Slovakia

Location

Site Reference ID/Investigator# 3960

Piešťany, 92112, Slovakia

Location

Site Reference ID/Investigator# 7177

Berea, Durban, 4001, South Africa

Location

Site Reference ID/Investigator# 7175

Cape Town, 7405, South Africa

Location

Site Reference ID/Investigator# 7178

Cape Town, 7500, South Africa

Location

Site Reference ID/Investigator# 7176

Port Elizabeth, 6045, South Africa

Location

Site Reference ID/Investigator# 7172

Pretoria, 0028, South Africa

Location

Site Reference ID/Investigator# 7174

Soweto, 2013, South Africa

Location

Site Reference ID/Investigator# 3955

A Coruña, 15006, Spain

Location

Site Reference ID/Investigator# 13661

Bilbao, 48013, Spain

Location

Site Reference ID/Investigator# 3930

Elche (Alicante), 03203, Spain

Location

Site Reference ID/Investigator# 8524

Madrid, 28006, Spain

Location

Site Reference ID/Investigator# 3956

Madrid, 28007, Spain

Location

Site Reference ID/Investigator# 3943

Madrid, 28034, Spain

Location

Site Reference ID/Investigator# 3931

Madrid, 28046, Spain

Location

Site Reference ID/Investigator# 3957

Oviedo, 33006, Spain

Location

Site Reference ID/Investigator# 3954

Santiago de Compostela, 15706, Spain

Location

Site Reference ID/Investigator# 3932

Zaragoza, 50009, Spain

Location

Site Reference ID/Investigator# 4015

Eskilstuna, SE-631 88, Sweden

Location

Site Reference ID/Investigator# 3984

Falun, SE-79182, Sweden

Location

Site Reference ID/Investigator# 4016

Malmo, 20502, Sweden

Location

Site Reference ID/Investigator# 4014

Stockholm, 171 76, Sweden

Location

Site Reference ID/Investigator# 4017

Uppsala, 75185, Sweden

Location

Site Reference ID/Investigator# 4012

Bath, BA1 1RL, United Kingdom

Location

Site Reference ID/Investigator# 8495

Huddersfield, HD3 3EA, United Kingdom

Location

Site Reference ID/Investigator# 4048

Leeds, LS7 4SA, United Kingdom

Location

Site Reference ID/Investigator# 4013

London, SE1 9RT, United Kingdom

Location

Site Reference ID/Investigator# 4046

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Site Reference ID/Investigator# 4047

Oxford, OX3 7LD, United Kingdom

Location

Site Reference ID/Investigator# 3985

Southampton, S016 6YD, United Kingdom

Location

Site Reference ID/Investigator# 7977

York, YO31 8HE, United Kingdom

Location

Related Publications (6)

• Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

  PMID: 31707982 DERIVED

• Smolen JS, van Vollenhoven RF, Florentinus S, Chen S, Suboticki JL, Kavanaugh A. Predictors of disease activity and structural progression after treatment with adalimumab plus methotrexate or continued methotrexate monotherapy in patients with early rheumatoid arthritis and suboptimal response to methotrexate. Ann Rheum Dis. 2018 Nov;77(11):1566-1572. doi: 10.1136/annrheumdis-2018-213502. Epub 2018 Aug 3.

  PMID: 30076156 DERIVED

• Kavanaugh A, van Vollenhoven RF, Fleischmann R, Emery P, Sainsbury I, Florentinus S, Chen S, Guerette B, Kupper H, Smolen JS. Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis. Ann Rheum Dis. 2018 Feb;77(2):289-292. doi: 10.1136/annrheumdis-2017-211871. Epub 2017 Nov 16.

  PMID: 29146743 DERIVED

• Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.

  PMID: 29018564 DERIVED

• Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

  PMID: 27338778 DERIVED

• Smolen JS, Emery P, Fleischmann R, van Vollenhoven RF, Pavelka K, Durez P, Guerette B, Kupper H, Redden L, Arora V, Kavanaugh A. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. 2014 Jan 25;383(9914):321-32. doi: 10.1016/S0140-6736(13)61751-1. Epub 2013 Oct 26.

  PMID: 24168956 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System 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: Abbott

1-800-633-9110

Study Officials

• Laura Redden, MD, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: December 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 18, 2012
• Results First Posted: September 29, 2011

Record last verified: 2012-04

Locations

PR (4); ME (7); NL (2); DE (14); GB (8); FR (4); US (49); NZ (4); AU (3); BE (7); HU (3); NO (5); CZ (5); SL (2); ES (10); PL (4); SE (5); AR (5); CA (17); ZA (6)