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RAPID 1 Trial
CIMZIA has been the subject of an extensive clinical trial program involving a substantial population of patients with moderately to severely active RA
The efficacy and tolerability of CIMZIA in treating rheumatoid arthritis (RA) have been assessed in randomized, double-blind, placebo-controlled studies in adults with moderately to severely active RA.1 These studies show that CIMZIA offers both rapid and sustained relief of the signs and symptoms of RA, with an ACR20 response as early as 1 week2 and symptomatic benefit through 100 weeks.3
- The 52-week RAPID 1 (n=982) and simultaneous 24-week RAPID 2 (n=619) were similarly designed, multicenter, randomized, double-blind, placebo-controlled trials.2,4 In both, patients with active RA failing on methotrexate (MTX) were randomized to CIMZIA (400 mg or 200 mg every 2 weeks) versus placebo, all on background MTX.2,4 A phase 3 open-label extension study to RAPID 1 is evaluating the long-term efficacy and safety of CIMZIA (400 mg every 2 weeks) plus MTX and has reported findings from a 2-year analysis3
- The FDA-approved dose of CIMZIA is 200 mg every other week or 400 mg every 4 weeks after initial dosing
Learn more about:
RAPID 1 study design
The RAPID 1 trial was a 52-week, phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 982 adults with moderately to severely active RA and inadequate response to MTX. The study was conducted between February 2005 and October 2006.2
Objective
To evaluate the efficacy and safety of 2 dosage regimens of subcutaneous lyophilized CIMZIA plus MTX in patients with active RA and an inadequate response to MTX alone.
Patient population
Inclusion criteria2:
- Adults with RA diagnosis for ≥6 months but <15 years
- Active disease (≥9 tender and 9 swollen joints) at baseline
- ESR ≥30 mm/hr OR C-reactive protein >15 mg/L
- On MTX for ≥6 months, at stable dosage (≥10 mg/wk) for ≥2 months prior to baseline
Exclusion criteria2:
- Diagnosis of any other inflammatory or noninflammatory arthritis
- History of tuberculosis (TB) or chest x-ray showing active or latent TB
- History of severe hypersensitivity or anaphylactic reaction to biologic therapy
- Prior failure to respond to anti-TNF therapy
RAPID 1: Patient baseline demographics and characteristics were similar across treatment groups2*
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- The FDA-approved dose of CIMZIA is 200 mg every other week or 400 mg every 4 weeks after initial dosing
Protocol
- Patients were randomized into 3 treatment groups2:
- CIMZIA 200 mg (n=393) every 2 weeks plus weekly MTX after an initial starting dose of CIMZIA 400 mg at Weeks 0, 2, and 4
- CIMZIA 400 mg (n=390) every 2 weeks beginning at Week 0 plus weekly MTX
- Placebo (n=199) every 2 weeks plus weekly MTX
- All disease-modifying antirheumatic drugs (DMARDs), except MTX, were discontinued prior to baseline. Concomitant oral corticosteroids, NSAIDs, COX-2 inhibitors, and analgesics were permitted; parenteral corticosteroids were prohibited2
- Patients who failed to achieve an ACR20 response at Weeks 12 and 14 were designated treatment failures and withdrawn at Week 16 (“withdrawers”)2 Withdrawers underwent radiographic assessment at time of withdrawal and at 52 weeks2
- All patients (those withdrawing at Week 16 and those completing 52 weeks) were offered enrollment in an open-label extension study of CIMZIA 400 mg every 2 weeks plus MTX2
RAPID 1 Patient Flow (Pivotal Trial through Open-Label Extension)3
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- The FDA-approved dose of CIMZIA is 200 mg every other week or 400 mg every 4 weeks after initial dosing
Primary end points2
- ACR20 (20% improvement) response rate at Week 24 (ACR20)
- Mean change from baseline in modified total Sharp score (mTSS) at Week 52
Secondary end points2
- Change from baseline in mTSS at Week 24
- Change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 24 and 52
- ACR20 responder rate at Week 52
- ACR50 (50% improvement) and ACR70 (70% improvement) responder rates at Weeks 24 and 52
- Mean change from baseline in:
- Erosion and joint space narrowing scores
- Swollen (n=66) and tender (n=68) joint counts
- Physician and patient global assessments of disease activity
- Patient assessment of arthritis pain
- Physical function (measured by HAQ-DI)
- Disease Activity Score 28-joint assessment
- Level of acute-phase reactant (ESR, CRP)
Efficacy and safety evaluations2
- Efficacy and safety assessments were made at Weeks 1 and 2, then every 2 weeks until Week 16, and then every 4 weeks until Week 52
- Radiographs of the hands and feet were taken at baseline, Week 24 (or at early withdrawal), and Week 52
- Adverse events (AEs) were monitored at each visit. Any AE arising after the first dose of study medication up to 12 weeks after the final dose was considered a treatment-emergent AE
Learn more about:
RAPID 1 early clinical response (Weeks 1-4)
RAPID 1 sustained clinical response (Weeks 12-52)
References:
1. CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2009.
2. Keystone E, Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58:3319-3329.
3. Keystone EC, Schiff M, Mease P, et al. Combination therapy with certolizumab pegol plus methotrexate maintains long-term efficacy in the treatment of rheumatoid arthritis: a 2-year analysis. Poster presented at: American College of Rheumatology Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA.
4. Smolen JS, Landewé RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomized controlled trial. Ann Rheum Dis. 2009;68:797-804.
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Your patients may be
eligible to save up to
$500 per pack on
CIMZIA prescriptions
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