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The FAST4WARD Trial
A randomized, placebo-controlled trial evaluating CIMZIA monotherapy after DMARD failure in patients with active rheumatoid arthritis (RA)
The FAST4WARD Study was a 24-week, multicenter, randomized, double-blind, placebo-controlled trial in 200 adults with active RA who had failed at least 1 prior disease-modifying antirheumatic drug (DMARD). The study was conducted between June 2003 and July 2004.1
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Objective
To evaluate the efficacy and safety of subcutaneous lyophilized CIMZIA 400 mg monotherapy administered every 4 weeks versus placebo.1
Patient population
Inclusion criteria1:
- Adults with RA diagnosis for ≥6 months
- Prior treatment failure with at least 1 DMARD
- Active disease (≥9 tender and ≥9 swollen joints) at baseline
- One or more of the following:
- ≥45 minutes of morning stiffness
- ESR ≥28 mm/hr
- C-reactive protein >10 mg/L
Exclusion criteria1:
- Diagnosis of any other inflammatory arthritis
- History of chronic or serious infection or current infection
- History of tuberculosis (TB) or tests suggesting TB
- RA treatment with biologic therapy in prior 6 months or any prior anti-TNF therapy
Patient baseline demographics and characteristics were similar between treatment groups1
Protocol
- Patients were randomized into 2 treatment groups1:
- CIMZIA 400 mg (n=111) every 4 weeks from baseline to Week 20
- Placebo (n=109) every 4 weeks from baseline to Week 20
- Concomitant oral corticosteroids, NSAIDs, and analgesics were permitted; intra-/periarticular, IM, and parenteral corticosteroids were prohibited1
Primary end point
- ACR20 response rate at Week 241:
- Patients achieving a 20% improvement (per ACR20 criteria) over baseline at Week 24 were considered responders1
- Patients who withdrew from the study for any reason were considered nonresponders1
Secondary end points
- ACR50 and ACR70 response1
- ACR component scores1
- Disease activity score (28-joint Disease Activity Score ESR 3)1
- Patient-reported outcomes (physical function, HRQoL, pain,
and fatigue)1
- Safety1
Efficacy and safety evaluations
- Efficacy and safety assessments were made at baseline and at Weeks 1, 2, and 4, then every 4 weeks through Week 24. An additional safety assessment was made 12 weeks after the final dose1
- 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 AE1
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FAST4WARD results
Reference:
1. Fleischmann R, Vencovsky J, van Vollenhoven RF, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009;68:805-811.
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Your patients may be
eligible to save up to
$500 per pack on
CIMZIA prescriptions
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