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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)


Phase 4
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

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 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.

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.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Outcome Description:

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.

Outcome Time Frame:

Week 78

Safety Issue:

No

Principal Investigator

Laura Redden, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

M06-810

NCT ID:

NCT00420927

Start Date:

December 2006

Completion Date:

July 2010

Related Keywords:

  • Rheumatoid Arthritis
  • Early Rheumatoid Arthritis
  • Tumor Necrosis Factor Optimization
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Site Reference ID/Investigator# 4560Birmingham, Alabama  35205
Site Reference ID/Investigator# 4547Birmingham, Alabama  35294-7201
Site Reference ID/Investigator# 6222Huntsville, Alabama  35801
Site Reference ID/Investigator# 4537Mobile, Alabama  36608
Site Reference ID/Investigator# 6758Tuscaloosa, Alabama  35406
Site Reference ID/Investigator# 9323Hemet, California  92543
Site Reference ID/Investigator# 4568La Jolla, California  92037-0943
Site Reference ID/Investigator# 4535Palm Desert, California  92260
Site Reference ID/Investigator# 4571Santa Monica, California  90404
Site Reference ID/Investigator# 9271Torrance, California  90505
Site Reference ID/Investigator# 10746Victorville, California  92395
Site Reference ID/Investigator# 4559Denver, Colorado  80230
Site Reference ID/Investigator# 6229Aventura, Florida  33180
Site Reference ID/Investigator# 10603Lake Mary, Florida  32746
Site Reference ID/Investigator# 9325Orange Park, Florida  32073
Site Reference ID/Investigator# 4550Palm Harbor, Florida  34684
Site Reference ID/Investigator# 4570Sarasota, Florida  34239
Site Reference ID/Investigator# 4601Tampa, Florida  33614
Site Reference ID/Investigator# 4552Vero Beach, Florida  32960
Site Reference ID/Investigator# 10745Meridian, Idaho  83642
Site Reference ID/Investigator# 4548Chicago, Illinois  60612
Site Reference ID/Investigator# 4557Springfield, Illinois  62704
Site Reference ID/Investigator# 4605Wichita, Kansas  67203
Site Reference ID/Investigator# 10741Wheaton, Maryland  20902
Site Reference ID/Investigator# 6417Fall River, Massachusetts  02720
Site Reference ID/Investigator# 4561Dover, New Hampshire  03820
Site Reference ID/Investigator# 11222Freehold, New Jersey  07728
Site Reference ID/Investigator# 6228Passaic, New Jersey  07055
Site Reference ID/Investigator# 4544Albuquerque, New Mexico  87102
Site Reference ID/Investigator# 12821Bronx, New York  10461
Site Reference ID/Investigator# 4534Orchard Park, New York  14127
Site Reference ID/Investigator# 9324Plainview, New York  11803
Site Reference ID/Investigator# 4600Smithtown, New York  11787
Site Reference ID/Investigator# 4549Mayfield Village, Ohio  44143
Site Reference ID/Investigator# 6227Bend, Oregon  97701
Site Reference ID/Investigator# 4546Duncansville, Pennsylvania  16635
Site Reference ID/Investigator# 4564West Reading, Pennsylvania  19611-1124
Site Reference ID/Investigator# 4558Wexford, Pennsylvania  15090
Site Reference ID/Investigator# 4533Charleston, South Carolina  29406
Site Reference ID/Investigator# 7482Greenville, South Carolina  29601
Site Reference ID/Investigator# 10743Jackson, Tennessee  38305
Site Reference ID/Investigator# 4562Nashville, Tennessee  37205
Site Reference ID/Investigator# 4536Dallas, Texas  75231
Site Reference ID/Investigator# 4538Houston, Texas  77074
Site Reference ID/Investigator# 6899San Antonio, Texas  78217
Site Reference ID/Investigator# 6381Tyler, Texas  75701
Site Reference ID/Investigator# 10744Seattle, Washington  98133
Site Reference ID/Investigator# 4545Glendale, Wisconsin  53217
Site Reference ID/Investigator# 4572Oak Creek, Wisconsin  53154