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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott
Study ID
NCT00420927
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
  • 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.
  • placebo — BIOLOGICAL
    Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

Study Details

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).

Key Dates

Start date
Dec 31, 2006
Status verified
Apr 2012
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
1,032 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

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 ]

Locations (49)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 4547BirminghamAlabama35294-7201-
Site Reference ID/Investigator# 4560BirminghamAlabama35205-
Site Reference ID/Investigator# 6222HuntsvilleAlabama35801-
Site Reference ID/Investigator# 4537MobileAlabama36608-
Site Reference ID/Investigator# 6758TuscaloosaAlabama35406-
Site Reference ID/Investigator# 9323HemetCalifornia92543-
Site Reference ID/Investigator# 4568La JollaCalifornia92037-0943-
Site Reference ID/Investigator# 4535Palm DesertCalifornia92260-
Site Reference ID/Investigator# 4571Santa MonicaCalifornia90404-
Site Reference ID/Investigator# 9271TorranceCalifornia90505-
Site Reference ID/Investigator# 10746VictorvilleCalifornia92395-
Site Reference ID/Investigator# 4559DenverColorado80230-
Site Reference ID/Investigator# 6229AventuraFlorida33180-
Site Reference ID/Investigator# 10603Lake MaryFlorida32746-
Site Reference ID/Investigator# 9325Orange ParkFlorida32073-
Site Reference ID/Investigator# 4550Palm HarborFlorida34684-
Site Reference ID/Investigator# 4570SarasotaFlorida34239-
Site Reference ID/Investigator# 4601TampaFlorida33614-
Site Reference ID/Investigator# 4552Vero BeachFlorida32960-
Site Reference ID/Investigator# 10745MeridianIdaho83642-
Site Reference ID/Investigator# 4548ChicagoIllinois60612-
Site Reference ID/Investigator# 4557SpringfieldIllinois62704-
Site Reference ID/Investigator# 4605WichitaKansas67203-
Site Reference ID/Investigator# 10741WheatonMaryland20902-
Site Reference ID/Investigator# 6417Fall RiverMassachusetts02720-
Site Reference ID/Investigator# 4561DoverNew Hampshire03820-
Site Reference ID/Investigator# 11222FreeholdNew Jersey07728-
Site Reference ID/Investigator# 6228PassaicNew Jersey07055-
Site Reference ID/Investigator# 4544AlbuquerqueNew Mexico87102-
Site Reference ID/Investigator# 4534Orchard ParkNew York14127-
Site Reference ID/Investigator# 9324PlainviewNew York11803-
Site Reference ID/Investigator# 4600SmithtownNew York11787-
Site Reference ID/Investigator# 12821The BronxNew York10461-
Site Reference ID/Investigator# 4549Mayfield VillageOhio44143-
Site Reference ID/Investigator# 6227BendOregon97701-
Site Reference ID/Investigator# 4546DuncansvillePennsylvania16635-
Site Reference ID/Investigator# 4564West ReadingPennsylvania19611-1124-
Site Reference ID/Investigator# 4558WexfordPennsylvania15090-
Site Reference ID/Investigator# 4533CharlestonSouth Carolina29406-
Site Reference ID/Investigator# 7482GreenvilleSouth Carolina29601-
Site Reference ID/Investigator# 10743JacksonTennessee38305-
Site Reference ID/Investigator# 4562NashvilleTennessee37205-
Site Reference ID/Investigator# 4536DallasTexas75231-
Site Reference ID/Investigator# 4538HoustonTexas77074-
Site Reference ID/Investigator# 6899San AntonioTexas78217-
Site Reference ID/Investigator# 6381TylerTexas75701-
Site Reference ID/Investigator# 10744SeattleWashington98133-
Site Reference ID/Investigator# 4545GlendaleWisconsin53217-
Site Reference ID/Investigator# 4572Oak CreekWisconsin53154-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Site Reference ID/Investigator# 4547· Birmingham, ALSite Reference ID/Investigator# 4560· Birmingham, ALSite Reference ID/Investigator# 6222· Huntsville, ALSite Reference ID/Investigator# 4537· Mobile, ALSite Reference ID/Investigator# 6758· Tuscaloosa, ALSite Reference ID/Investigator# 9323· Hemet, CA

Related Studies