Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00420927




Registration number
NCT00420927
Ethics application status
Date submitted
9/01/2007
Date registered
11/01/2007
Date last updated
18/04/2012

Titles & IDs
Public title
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
Scientific 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)
Secondary ID [1] 0 0
2006-004139-31
Secondary ID [2] 0 0
M06-810
Universal Trial Number (UTN)
Trial acronym
OPTIMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - adalimumab
Treatment: Drugs - methotrexate
Treatment: Other - placebo

Experimental: ADA+MTX/PBO+MTX (Arm 1) - Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2

Experimental: ADA+MTX/ADA+MTX (Arm2) - Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2

Experimental: ADA+MTX/OL ADA+MTX (Arm 3) - Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA + MTX during Period 2

Experimental: PBO+MTX/PBO+MTX (Arm 4) - Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2

Experimental: PBO+MTX/OL ADA+MTX (Arm 5) - Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2.


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

Treatment: Drugs: methotrexate
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.

Treatment: Other: placebo
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 78
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 78
Secondary outcome [2] 0 0
Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78
Timepoint [2] 0 0
Week 78
Secondary outcome [3] 0 0
Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78
Timepoint [3] 0 0
Week 78
Secondary outcome [4] 0 0
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78
Timepoint [4] 0 0
Week 78
Secondary outcome [5] 0 0
Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78
Timepoint [5] 0 0
Week 78
Secondary outcome [6] 0 0
Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78
Timepoint [6] 0 0
Week 78
Secondary outcome [7] 0 0
Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78
Timepoint [7] 0 0
Week 78
Secondary outcome [8] 0 0
Change From Baseline in DAS28 Score at Week 78
Timepoint [8] 0 0
Baseline to Week 78
Secondary outcome [9] 0 0
Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78
Timepoint [9] 0 0
Week 78
Secondary outcome [10] 0 0
Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78
Timepoint [10] 0 0
Week 78
Secondary outcome [11] 0 0
Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78
Timepoint [11] 0 0
Week 78
Secondary outcome [12] 0 0
Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78
Timepoint [12] 0 0
Week 78
Secondary outcome [13] 0 0
Change From Baseline in CDAI Score at Week 78
Timepoint [13] 0 0
Baseline to Week 78
Secondary outcome [14] 0 0
Change From Baseline in SDAI Score at Week 78
Timepoint [14] 0 0
Baseline to Week 78
Secondary outcome [15] 0 0
Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78
Timepoint [15] 0 0
Baseline to Week 78
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Week 78
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
Week 78
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Week 78

Eligibility
Key inclusion criteria
Inclusion Criteria

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* 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.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
1032
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 8380 - Campsie, Sydney
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 6954 - Clayton
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 6940 - Malvern East
Recruitment postcode(s) [1] 0 0
2194 - Campsie, Sydney
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Quilmes
Country [24] 0 0
Argentina
State/province [24] 0 0
San Miguel de Tucuman
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Genk
Country [29] 0 0
Belgium
State/province [29] 0 0
Gilly
Country [30] 0 0
Belgium
State/province [30] 0 0
Liege
Country [31] 0 0
Belgium
State/province [31] 0 0
Mechelen
Country [32] 0 0
Belgium
State/province [32] 0 0
Sint-Niklaas
Country [33] 0 0
Belgium
State/province [33] 0 0
Yvoir
Country [34] 0 0
Canada
State/province [34] 0 0
Burlington
Country [35] 0 0
Canada
State/province [35] 0 0
Edmonton
Country [36] 0 0
Canada
State/province [36] 0 0
Halifax
Country [37] 0 0
Canada
State/province [37] 0 0
Hamilton
Country [38] 0 0
Canada
State/province [38] 0 0
Montreal
Country [39] 0 0
Canada
State/province [39] 0 0
Ottawa
Country [40] 0 0
Canada
State/province [40] 0 0
Richmond
Country [41] 0 0
Canada
State/province [41] 0 0
Sainte-Foy, Quebec
Country [42] 0 0
Canada
State/province [42] 0 0
Sarnia
Country [43] 0 0
Canada
State/province [43] 0 0
St. John's
Country [44] 0 0
Canada
State/province [44] 0 0
Toronto
Country [45] 0 0
Canada
State/province [45] 0 0
Victoria
Country [46] 0 0
Canada
State/province [46] 0 0
Windsor
Country [47] 0 0
Canada
State/province [47] 0 0
Winnipeg
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Brno
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Hradec Kralove
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Ostrava
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Prague 2
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Uherske Hradiste
Country [53] 0 0
France
State/province [53] 0 0
Amiens
Country [54] 0 0
France
State/province [54] 0 0
Le Mans
Country [55] 0 0
France
State/province [55] 0 0
Paris Cedex 14
Country [56] 0 0
France
State/province [56] 0 0
Strasbourg
Country [57] 0 0
Germany
State/province [57] 0 0
Bad Nauheim
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin-Buch
Country [59] 0 0
Germany
State/province [59] 0 0
Damp
Country [60] 0 0
Germany
State/province [60] 0 0
Duesseldorf
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt/Main
Country [62] 0 0
Germany
State/province [62] 0 0
Frankfurt
Country [63] 0 0
Germany
State/province [63] 0 0
Freiburg
Country [64] 0 0
Germany
State/province [64] 0 0
Halle
Country [65] 0 0
Germany
State/province [65] 0 0
Hofheim
Country [66] 0 0
Germany
State/province [66] 0 0
Munich
Country [67] 0 0
Germany
State/province [67] 0 0
Osnabrueck
Country [68] 0 0
Germany
State/province [68] 0 0
Ratingen
Country [69] 0 0
Germany
State/province [69] 0 0
Vogelsang-Gommern
Country [70] 0 0
Germany
State/province [70] 0 0
Zerbst
Country [71] 0 0
Hungary
State/province [71] 0 0
Budapest
Country [72] 0 0
Hungary
State/province [72] 0 0
Debrecen
Country [73] 0 0
Mexico
State/province [73] 0 0
Aguascallentes
Country [74] 0 0
Mexico
State/province [74] 0 0
Leon, Guanajuato
Country [75] 0 0
Mexico
State/province [75] 0 0
Mexico City
Country [76] 0 0
Netherlands
State/province [76] 0 0
Arnem
Country [77] 0 0
Netherlands
State/province [77] 0 0
Hilversum
Country [78] 0 0
New Zealand
State/province [78] 0 0
Auckland 6
Country [79] 0 0
New Zealand
State/province [79] 0 0
Hamilton
Country [80] 0 0
New Zealand
State/province [80] 0 0
Timaru
Country [81] 0 0
New Zealand
State/province [81] 0 0
Wellington
Country [82] 0 0
Norway
State/province [82] 0 0
Alesund
Country [83] 0 0
Norway
State/province [83] 0 0
Kristiansand S
Country [84] 0 0
Norway
State/province [84] 0 0
Levanger
Country [85] 0 0
Norway
State/province [85] 0 0
Lillehammer
Country [86] 0 0
Norway
State/province [86] 0 0
Trondheim
Country [87] 0 0
Poland
State/province [87] 0 0
Bydgoszcz
Country [88] 0 0
Poland
State/province [88] 0 0
Katowice
Country [89] 0 0
Poland
State/province [89] 0 0
Lublin
Country [90] 0 0
Poland
State/province [90] 0 0
Wroclaw
Country [91] 0 0
Puerto Rico
State/province [91] 0 0
Caguas
Country [92] 0 0
Puerto Rico
State/province [92] 0 0
Ponce
Country [93] 0 0
Puerto Rico
State/province [93] 0 0
San Juan
Country [94] 0 0
Slovakia
State/province [94] 0 0
Piestany
Country [95] 0 0
South Africa
State/province [95] 0 0
Berea, Durban
Country [96] 0 0
South Africa
State/province [96] 0 0
Cape Town
Country [97] 0 0
South Africa
State/province [97] 0 0
Port Elizabeth
Country [98] 0 0
South Africa
State/province [98] 0 0
Pretoria
Country [99] 0 0
South Africa
State/province [99] 0 0
Soweto
Country [100] 0 0
Spain
State/province [100] 0 0
A Coruna
Country [101] 0 0
Spain
State/province [101] 0 0
Bilbao
Country [102] 0 0
Spain
State/province [102] 0 0
Elche (Alicante)
Country [103] 0 0
Spain
State/province [103] 0 0
Madrid
Country [104] 0 0
Spain
State/province [104] 0 0
Oviedo
Country [105] 0 0
Spain
State/province [105] 0 0
Santiago de Compostela
Country [106] 0 0
Spain
State/province [106] 0 0
Zaragoza
Country [107] 0 0
Sweden
State/province [107] 0 0
Eskilstuna
Country [108] 0 0
Sweden
State/province [108] 0 0
Falun
Country [109] 0 0
Sweden
State/province [109] 0 0
Malmoe
Country [110] 0 0
Sweden
State/province [110] 0 0
Stockholm
Country [111] 0 0
Sweden
State/province [111] 0 0
Uppsala
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Bath
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Huddersfield
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Leeds
Country [115] 0 0
United Kingdom
State/province [115] 0 0
London
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Newcastle upon Tyne
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Oxford
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Southampton
Country [119] 0 0
United Kingdom
State/province [119] 0 0
York

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Laura Redden, MD, PhD
Address 0 0
Abbott
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00420927