Efficacy - OA/RA

Study Descriptions

Bensen et al was a 12-week, prospective, randomized, double-blind, parallel-group study to compare the efficacy and safety of CELEBREX 50 mg, 100 mg, and 200 mg BID with naproxen 500 mg BID or placebo in patients with OA of the knee. Primary end points were patients' global assessments of arthritic condition, patients' assessment of pain on a visual analog scale (VAS), and physicians' global assessment of arthritic condition. Secondary end point: WOMAC index. The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index is a multidimensional, disease-specific, self-administered health status measure assessing pain, stiffness, and physical function in patients with OA. Range of possible scores is 0-96. The range of possible scores for physical functioning is 0-68.

CELEBREX 50 mg BID and 200 mg BID are not approved OA doses in the United States, and data for these doses are not shown.

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Data on file, Pfizer Inc (patients previously treated with Rx naproxen and ibuprofen). Two identical 6-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled trials to compare the efficacy of CELEBREX 200 mg QD and placebo after 6 weeks of therapy in the treatment of symptoms associated with OA flare for patients who had previously been nonresponsive to, or did not tolerate, treatment with both Rx naproxen and ibuprofen. The previous treatment durations of naproxen (at least 750 mg/day) and ibuprofen (at least 1200 mg/day) had to be a minimum of 2 weeks if failure was due to lack of efficacy and for any duration if failure was due to lack of tolerability. Patients were randomized to receive CELEBREX 200 mg QD or placebo. Primary end point was patients' assessment of arthritis pain using a 100-mm VAS. Secondary end point was Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, a multidimensional, disease-specific, self-administered health status measure assessing pain, stiffness, and physical function in patients with OA. Range of possible scores: 0-96.

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Strand et al was a prospective, randomized, double-blind, parallel-group, multicenter study in patients with OA of the hip or knee who required NSAIDs to determine whether continuous daily CELEBREX was more efficacious in preventing OA flares than CELEBREX used only during OA flares of the knee/hip. After a 14-day washout period to induce flare, patients were treated with CELEBREX 200 mg daily for 14 days. Patients whose flare resolved with CELEBREX were randomized to 22 weeks of CELEBREX 200 mg daily every day or CELEBREX 200 mg only during spontaneous flare. Acetaminophen was permitted after randomization as rescue medication for OA pain regardless of flare. Primary end point was number of OA flares per month after randomization.

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Simon et al was a 12-week, randomized, multicenter, double-blind, parallel-group trial of RA patients that compared CELEBREX 100 mg, 200 mg, or 400 mg§ BID, naproxen 500 mg BID, and placebo. Its purpose was to test whether CELEBREX has efficacy as an anti-inflammatory and analgesic compared with conventional Rx NSAIDs in patients with RA. Primary end points were American College of Rheumatology (ACR-20) Responder Index, patient's global assessment of arthritic condition, number of tender/painful joints, number of swollen joints, and physician's global assessment of arthritic condition score.

§CELEBREX 400 mg BID daily is not an approved RA dose, and data for this dose are not shown.

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Karim et al was a single-blind, randomized, 2-period crossover study in 14 adult female patients who had been taking a stable weekly methotrexate (MTX) dose for a minimum of 3 months. Its purpose was to determine the effects of CELEBREX on the renal clearance and plasma pharmacokinetic profile of stable methotrexate doses in patients with RA. Patients were randomized to receive a morning dose of MTX concomitantly with either CELEBREX 200 mg BID or placebo for a period of 7 days. After 7 days, the patients were switched to receive the alternate treatment. Blood samples for pharmacokinetic measurements of MTX were collected at 15 minutes prior to the patient taking MTX and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after administration of MTX on day 0 (MTX alone), and then again on days 7 and 14 (MTX plus CELEBREX or MTX plus placebo in a crossover fashion). Renal clearance was also evaluated.

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*Eligibility required. Terms and conditions apply. Full terms and conditions can be found at CELEBREX.com/savings-terms. This Savings Offer will be accepted only at participating pharmacies. This Savings Offer is not health insurance. No membership fees. Maximum savings of $1,750 per offer. This Savings Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs. This Savings Offer is not valid for prescriptions that are eligible to be reimbursed in whole by private insurance plans or other health or pharmacy benefit programs. For help with the CELEBREX Savings Offer, call 1-855-612-1956, visit CELEBREX.com, or write: Pfizer Inc., 235 E 42nd Street, New York, NY 10017.

References:
  1. Bensen WG, Fiechtner JJ, McMillen JI, et al. Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial. Mayo Clin Proc. 1999;74(11):1095-1105.
  2. Data on file. Pfizer Inc, New York, NY.
  3. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833-1840.
  4. Strand V, Simon LS, Dougados M, et al. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011;38(12):2625-2634.
  5. Simon LS, Weaver AL, Graham DY, et al. Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA. 1999;282(20):1921-1928.
  6. Karim A, Tolbert DS, Hunt TL, Hubbard RC, Harper KM, Geis GS. Celecoxib, a specific COX-2 inhibitor, has no significant effect on methotrexate pharmacokinetics in patients with rheumatoid arthritis. J Rheumatol. 1999;26(12):2539-2543.

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