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Rheumatoid ArthritisPhase 4OPTIMANCT00420927

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

A Phase 4 study testing adalimumab and methotrexate in people with Rheumatoid Arthritis, run by Abbott at 170 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
adalimumab and methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,032 participants
Where
170 sitesin 21 countries
Study dates
Dec 2006to Jul 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

170 sites in 21 countries.

170 sites in 21 countries

United States49 sites

  • Site Reference ID/Investigator# 4544

    Albuquerque, New Mexico, 87102

  • Site Reference ID/Investigator# 6229

    Aventura, Florida, 33180

  • Site Reference ID/Investigator# 6227

    Bend, Oregon, 97701

  • Site Reference ID/Investigator# 4560

    Birmingham, Alabama, 35205

  • Site Reference ID/Investigator# 4547

    Birmingham, Alabama, 35294-7201

  • Site Reference ID/Investigator# 4533

    Charleston, South Carolina, 29406

  • Site Reference ID/Investigator# 4548

    Chicago, Illinois, 60612

  • Site Reference ID/Investigator# 4536

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 4559

    Denver, Colorado, 80230

  • Site Reference ID/Investigator# 4561

    Dover, New Hampshire, 03820

  • Site Reference ID/Investigator# 4546

    Duncansville, Pennsylvania, 16635

  • Site Reference ID/Investigator# 6417

    Fall River, Massachusetts, 02720

  • Site Reference ID/Investigator# 11222

    Freehold, New Jersey, 07728

  • Site Reference ID/Investigator# 4545

    Glendale, Wisconsin, 53217

  • Site Reference ID/Investigator# 7482

    Greenville, South Carolina, 29601

  • Site Reference ID/Investigator# 9323

    Hemet, California, 92543

  • Site Reference ID/Investigator# 4538

    Houston, Texas, 77074

  • Site Reference ID/Investigator# 6222

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 10743

    Jackson, Tennessee, 38305

  • Site Reference ID/Investigator# 4568

    La Jolla, California, 92037-0943

  • Site Reference ID/Investigator# 10603

    Lake Mary, Florida, 32746

  • Site Reference ID/Investigator# 4549

    Mayfield Village, Ohio, 44143

  • Site Reference ID/Investigator# 10745

    Meridian, Idaho, 83642

  • Site Reference ID/Investigator# 4537

    Mobile, Alabama, 36608

  • Site Reference ID/Investigator# 4562

    Nashville, Tennessee, 37205

  • Site Reference ID/Investigator# 4572

    Oak Creek, Wisconsin, 53154

  • Site Reference ID/Investigator# 9325

    Orange Park, Florida, 32073

  • Site Reference ID/Investigator# 4534

    Orchard Park, New York, 14127

  • Site Reference ID/Investigator# 4535

    Palm Desert, California, 92260

  • Site Reference ID/Investigator# 4550

    Palm Harbor, Florida, 34684

  • Site Reference ID/Investigator# 6228

    Passaic, New Jersey, 07055

  • Site Reference ID/Investigator# 9324

    Plainview, New York, 11803

  • Site Reference ID/Investigator# 6899

    San Antonio, Texas, 78217

  • Site Reference ID/Investigator# 4571

    Santa Monica, California, 90404

  • Site Reference ID/Investigator# 4570

    Sarasota, Florida, 34239

  • Site Reference ID/Investigator# 10744

    Seattle, Washington, 98133

  • Site Reference ID/Investigator# 4600

    Smithtown, New York, 11787

  • Site Reference ID/Investigator# 4557

    Springfield, Illinois, 62704

  • Site Reference ID/Investigator# 4601

    Tampa, Florida, 33614

  • Site Reference ID/Investigator# 12821

    The Bronx, New York, 10461

  • Site Reference ID/Investigator# 9271

    Torrance, California, 90505

  • Site Reference ID/Investigator# 6758

    Tuscaloosa, Alabama, 35406

  • Site Reference ID/Investigator# 6381

    Tyler, Texas, 75701

  • Site Reference ID/Investigator# 4552

    Vero Beach, Florida, 32960

  • Site Reference ID/Investigator# 10746

    Victorville, California, 92395

  • Site Reference ID/Investigator# 4564

    West Reading, Pennsylvania, 19611-1124

  • Site Reference ID/Investigator# 4558

    Wexford, Pennsylvania, 15090

  • Site Reference ID/Investigator# 10741

    Wheaton, Maryland, 20902

  • Site Reference ID/Investigator# 4605

    Wichita, Kansas, 67203

Other trials in United States

Canada17 sites

  • Site Reference ID/Investigator# 6701

    Burlington, L7R 1E2

  • Site Reference ID/Investigator# 6834

    Edmonton, T5M 0H4

  • Site Reference ID/Investigator# 7197

    Halifax, B3H 4K4

  • Site Reference ID/Investigator# 3883

    Hamilton, L8N 1Y2

  • Site Reference ID/Investigator# 3884

    Hamilton, L8N 2B6

  • Site Reference ID/Investigator# 3907

    Montreal, H2L 1S6

  • Site Reference ID/Investigator# 3903

    Montreal, H3Z 2Z3

  • Site Reference ID/Investigator# 5178

    Ottawa, K2G 6E2

  • Site Reference ID/Investigator# 3904

    Richmond, V7C 5L9

  • Site Reference ID/Investigator# 3912

    Sainte-Foy, Quebec, G1W 4R4

  • Site Reference ID/Investigator# 3901

    Sarnia, N7T 5W6

  • Site Reference ID/Investigator# 3906

    St. John's, A1A 5E8

  • Site Reference ID/Investigator# 6542

    Toronto, M9B 1B1

  • Site Reference ID/Investigator# 3882

    Victoria, V8V 3P9

  • Site Reference ID/Investigator# 5616

    Windsor, N8X 5A6

  • Site Reference ID/Investigator# 5847

    Winnipeg, R3A 1M3

  • Site Reference ID/Investigator# 3905

    Winnipeg, R3A 1M4

Other trials in Canada

Germany14 sites

  • Site Reference ID/Investigator# 3926

    Bad Nauheim, D-61231

  • Site Reference ID/Investigator# 3928

    Buch, 13125

  • Site Reference ID/Investigator# 3978

    Damp, 24351

  • Site Reference ID/Investigator# 3924

    Düsseldorf, 40225

  • Site Reference ID/Investigator# 3965

    Frankfurt, 60590

  • Site Reference ID/Investigator# 3927

    Frankfurt am Main, 60596

  • Site Reference ID/Investigator# 3925

    Freiburg im Breisgau, 79106

  • Site Reference ID/Investigator# 4291

    Halle, 06120

  • Site Reference ID/Investigator# 8489

    Hofheim, D-65719

  • Site Reference ID/Investigator# 3923

    Munich, 80336

  • Site Reference ID/Investigator# 8483

    Osnabrück, D-49074

  • Site Reference ID/Investigator# 8486

    Ratingen, 40882

  • Site Reference ID/Investigator# 3919

    Vogelsang-Gommern, 39245

  • Site Reference ID/Investigator# 6637

    Zerbst, 39261

Other trials in Germany

Spain10 sites

  • Site Reference ID/Investigator# 3955

    A Coruña, 15006

  • Site Reference ID/Investigator# 13661

    Bilbao, 48013

  • Site Reference ID/Investigator# 3930

    Elche (Alicante), 03203

  • Site Reference ID/Investigator# 8524

    Madrid, 28006

  • Site Reference ID/Investigator# 3956

    Madrid, 28007

  • Site Reference ID/Investigator# 3943

    Madrid, 28034

  • Site Reference ID/Investigator# 3931

    Madrid, 28046

  • Site Reference ID/Investigator# 3957

    Oviedo, 33006

  • Site Reference ID/Investigator# 3954

    Santiago de Compostela, 15706

  • Site Reference ID/Investigator# 3932

    Zaragoza, 50009

Other trials in Spain

United Kingdom8 sites

  • Site Reference ID/Investigator# 4012

    Bath, BA1 1RL

  • Site Reference ID/Investigator# 8495

    Huddersfield, HD3 3EA

  • Site Reference ID/Investigator# 4048

    Leeds, LS7 4SA

  • Site Reference ID/Investigator# 4013

    London, SE1 9RT

  • Site Reference ID/Investigator# 4046

    Newcastle upon Tyne, NE7 7DN

  • Site Reference ID/Investigator# 4047

    Oxford, OX3 7LD

  • Site Reference ID/Investigator# 3985

    Southampton, S016 6YD

  • Site Reference ID/Investigator# 7977

    York, YO31 8HE

Other trials in United Kingdom

Belgium7 sites

  • Site Reference ID/Investigator# 3914

    Brussels, 1200

  • Site Reference ID/Investigator# 3909

    Genk, 3600

  • Site Reference ID/Investigator# 3881

    Gilly, 6060

  • Site Reference ID/Investigator# 3376

    Liège, 4000

  • Site Reference ID/Investigator# 6720

    Mechelen, 2800

  • Site Reference ID/Investigator# 6718

    Sint-Niklaas, 9100

  • Site Reference ID/Investigator# 3910

    Yvoir, 5530

Other trials in Belgium

Mexico7 sites

  • Site Reference ID/Investigator# 3824

    Aguascallentes, 20230

  • Site Reference ID/Investigator# 3822

    León, 37000

  • Site Reference ID/Investigator# 3825

    Mexico City, 10700

  • Site Reference ID/Investigator# 3951

    Mexico City, 10700

  • Site Reference ID/Investigator# 3890

    Mexico City, 14389

  • Site Reference ID/Investigator# 3823

    Mexico City, CP 1300

  • Site Reference ID/Investigator# 3891

    Mexico City, CP 14050

Other trials in Mexico

Austria6 sites

  • Site Reference ID/Investigator# 3915

    Graz, 8036

  • Site Reference ID/Investigator# 3911

    Graz, A-8020

  • Site Reference ID/Investigator# 3880

    Vienna, 1090

  • Site Reference ID/Investigator# 3885

    Vienna, 1100

  • Site Reference ID/Investigator# 3916

    Vienna, 1130

  • Site Reference ID/Investigator# 7792

    Vienna, 1160

Other trials in Austria

South Africa6 sites

  • Site Reference ID/Investigator# 7177

    Berea, Durban, 4001

  • Site Reference ID/Investigator# 7175

    Cape Town, 7405

  • Site Reference ID/Investigator# 7178

    Cape Town, 7500

  • Site Reference ID/Investigator# 7176

    Port Elizabeth, 6045

  • Site Reference ID/Investigator# 7172

    Pretoria, 0028

  • Site Reference ID/Investigator# 7174

    Soweto, 2013

Other trials in South Africa

Argentina5 sites

  • Site Reference ID/Investigator# 3886

    Buenos Aires, 1426AAL

  • Site Reference ID/Investigator# 3888

    Buenos Aires, C1015ABO

  • Site Reference ID/Investigator# 6346

    Buenos Aires, C1055AAF

  • Site Reference ID/Investigator# 3887

    Quilmes

  • Site Reference ID/Investigator# 3889

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Czechia5 sites

  • Site Reference ID/Investigator# 3968

    Brno, 65691

  • Site Reference ID/Investigator# 3971

    Hradec Králové, 500 05

  • Site Reference ID/Investigator# 5559

    Ostrava, 72200

  • Site Reference ID/Investigator# 3969

    Prague, 128 50

  • Site Reference ID/Investigator# 5548

    Uherské Hradiště, 686 01

Other trials in Czechia

Norway5 sites

  • Site Reference ID/Investigator# 7607

    Ålesund, N-6026

  • Site Reference ID/Investigator# 7935

    Kristiansand, 4615

  • Site Reference ID/Investigator# 7506

    Levanger, 7600

  • Site Reference ID/Investigator# 7511

    Lillehammer, N-2609

  • Site Reference ID/Investigator# 7500

    Trondheim, N-7006

Other trials in Norway

Sweden5 sites

  • Site Reference ID/Investigator# 4015

    Eskilstuna, SE-631 88

  • Site Reference ID/Investigator# 3984

    Falun, SE-79182

  • Site Reference ID/Investigator# 4016

    Malmö, 20502

  • Site Reference ID/Investigator# 4014

    Stockholm, 171 76

  • Site Reference ID/Investigator# 4017

    Uppsala, 75185

Other trials in Sweden

France4 sites

  • Site Reference ID/Investigator# 3982

    Amiens, 80054

  • Site Reference ID/Investigator# 3979

    Le Mans, 72037

  • Site Reference ID/Investigator# 3983

    Paris, 75679

  • Site Reference ID/Investigator# 3918

    Strasbourg, 67098

Other trials in France

New Zealand4 sites

  • Site Reference ID/Investigator# 8485

    Auckland

  • Site Reference ID/Investigator# 8488

    Hamilton

  • Site Reference ID/Investigator# 8496

    Timaru

  • Site Reference ID/Investigator# 8511

    Wellington

Other trials in New Zealand

Poland4 sites

  • Site Reference ID/Investigator# 3963

    Bydgoszcz, 85168

  • Site Reference ID/Investigator# 3962

    Katowice, 40635

  • Site Reference ID/Investigator# 5560

    Lublin, 20954

  • Site Reference ID/Investigator# 3961

    Wroclaw, 53-342

Other trials in Poland

Puerto Rico4 sites

  • Site Reference ID/Investigator# 3944

    Caguas, 00725

  • Site Reference ID/Investigator# 3937

    Ponce, 00716

  • Site Reference ID/Investigator# 3934

    San Juan, 00918

  • Site Reference ID/Investigator# 3935

    San Juan, 00936-5067

Other trials in Puerto Rico

Australia3 sites

  • Site Reference ID/Investigator# 8380

    Campsie, Sydney, 2194

  • Site Reference ID/Investigator# 6954

    Clayton, 3168

  • Site Reference ID/Investigator# 6940

    Malvern East, 3145

Other trials in Australia

Hungary3 sites

  • Site Reference ID/Investigator# 3921

    Budapest, 1023

  • Site Reference ID/Investigator# 3922

    Budapest, 1277

  • Site Reference ID/Investigator# 3920

    Debrecen, 4012

Other trials in Hungary

Netherlands2 sites

  • Site Reference ID/Investigator# 3947

    Arnhem, 6815 AD

  • Site Reference ID/Investigator# 3948

    Hilversum, 1213XZ

Other trials in Netherlands

Slovakia2 sites

  • Site Reference ID/Investigator# 3959

    Piešťany, 92112

  • Site Reference ID/Investigator# 3960

    Piešťany, 92112

Other trials in Slovakia

About this study

Official title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

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).

Read the detailed description

This was a 78-week, multicenter, randomized, double-blind, double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early RA. Subjects were randomized to receive adalimumab 40 mg every other week (eow) or placebo subcutaneous injections in combination with orally administered MTX for 26 weeks (Period 1). All subjects in all arms received open-label MTX weekly throughout the study (both Period 1 and Period 2).

At Weeks 22 and 26, subjects were assessed for achievement of low disease activity, defined as a DAS28 score below 3.2. DAS28 is a measure of RA disease activity calculated using the number of tender and swollen joints (out of a total of 28), C-reactive protein level (CRP, a blood marker of inflammation), and the patient's global assessment of disease activity (indicated by marking a 10 cm line between very good and very bad). Subjects who achieved low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were randomized to receive MTX monotherapy (placebo and MTX) or combination therapy (adalimumab and MTX) in a 1:1 ratio for the duration of Period 2 (52 weeks, i.e., to Week 78 of the study). Subjects achieving low disease activity at Week 22 and 26 in the placebo arm (MTX monotherapy) at the end of Period 1 continued to receive MTX monotherapy (and placebo injections in a blinded fashion) for the duration of Period 2. Subjects failing to achieve low disease activity at Week 22 and 26 at the end of Period 1 received open-label combination therapy during Period 2 regardless of treatment assignment in Period 1.

Being tested
adalimumab, methotrexate, placebo
Keywords
Early Rheumatoid Arthritis, Tumor Necrosis Factor Optimization
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adalimumabBiological

    Also called Humira, D2E7

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

  • methotrexateDrug

    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.

  • placeboBiological

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

Study groups in NCT00420927
Study groupRoleWhat they receive
ADA+MTX/PBO+MTX (Arm 1)ExperimentalCombination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
Receives: Biological: adalimumab; Drug: methotrexate; Biological: placebo
ADA+MTX/ADA+MTX (Arm2)ExperimentalCombination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
Receives: Biological: adalimumab; Drug: methotrexate
ADA+MTX/OL ADA+MTX (Arm 3)ExperimentalCombination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA + MTX during Period 2
Receives: Biological: adalimumab; Drug: methotrexate
PBO+MTX/PBO+MTX (Arm 4)ExperimentalMethotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
Receives: Drug: methotrexate; Biological: placebo
PBO+MTX/OL ADA+MTX (Arm 5)ExperimentalMethotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2.
Receives: Biological: adalimumab; Drug: methotrexate; Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 78

Secondary outcomes (18)

  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 1

    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.

    Measured: Week 78

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

    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. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.

    Measured: Week 78

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

    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. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.

    Measured: Week 78

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

    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. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

    Measured: Week 78

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

    Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).

    Measured: Week 78

  6. Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78

    Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).

    Measured: Week 78

  7. Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78

    Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).

    Measured: Week 78

  8. Change From Baseline in DAS28 Score at Week 78

    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. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.

    Measured: Baseline to Week 78

  9. Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78

    The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.

    Measured: Week 78

  10. Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78

    The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.

    Measured: Week 78

  11. Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78

    The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.

    Measured: Week 78

  12. Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78

    The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.

    Measured: Week 78

  13. Change From Baseline in CDAI Score at Week 78

    The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.

    Measured: Baseline to Week 78

  14. Change From Baseline in SDAI Score at Week 78

    The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.

    Measured: Baseline to Week 78

  15. Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78

    Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.

    Measured: Baseline to Week 78

  16. Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78

    In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. 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.

    Measured: Week 78

  17. Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78

    In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.

    Measured: Week 78

  18. Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78

    In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.

    Measured: Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00420927
Sponsor's protocol ID
M06-810
Other IDs
2006-004139-31
Acronym
OPTIMA
Status last verified
Apr 2012
First submitted
9 Jan 2007
Last updated
18 Apr 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 31707982

  • 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.

    PubMed 30076156

  • 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.

    PubMed 29146743

  • 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.

    PubMed 29018564

  • 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.

    PubMed 27338778

  • 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.

    PubMed 24168956

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adalimumab and methotrexate in people with Rheumatoid Arthritis, run by Abbott at 170 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Canada, Germany, Spain, United Kingdom and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 78). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00420927, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2012.

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