2005P-0127
CP 1
Volume 1

Citizen Petition

Tab 1 - Package insert for Arava Tablets (leflunomide)

Tab 2 - NDA 20905, Clinical Pharmacology and Biopharmaceutics Review(s) 2

Tab 3 - Letter dated June 23, 1998, from Quintiles to Sandra Cook, Project Manager, Division of Anti-Inflammatory, Analgesic, and Opthalmologic Drug Products, FDA

Tab 4 - Facsimile Transmission dated August 6, 1998 from Sandra Cook at FDA to Joan Bates at Quintiles

Tab 5 - Guidelines for the Management of Rheumatoid Arthritis. 2002 Update. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Arthritis & Rheum. 2002; 46: 328-346

Tab 6 - Management of Early Rheumatoid Arthritis. A National Clinical Guideline. Scottish Intercollegiate Guideline Network. December 2000

Tab 7 - McGonagle D, Green MJ, Proudman S, Richardson C, Veale D, O’Connor P et al. The majority of patients with rheumatoid arthritis have erosive disease at presentation when magnetic resonance imaging of the dominant hand is employed. Br. J. Rheumatol. 1997; 36 (Suppl): 230.

Tab 8 - Egsmose C, Lund B, Borg G, Petterson H, Berg E, Brodin U, et al. Patients with rheumatoid arthritis benefit from early 2nd line therapy: 5-year followup of a prospective double blind placebo controlled study. J. Rheumatol. 1995; 22: 2208-13.

Tab 9 - Tsakonas E. Fitzgerald AA, Fitzcharles MA, Vividino A, Thorne JC, M’Seffar A, et al. Consequences of the delayed therapy with second-line agents in rheumatoid arthritis: a 3 year followup on the hydroxychloroquine in early rheumatoid arthritis (HERA) study. J. Rheumatol. 2000; 27: 623-9.

Tab 10 - Symmons DPM, Jones MA, Scott DL, Prior P. Longterm mortality outcome in patients with rheumatoid arthritis: early presenters continue to do well. J. Rheumatol. 1998; 25: 1072-7.

Tab 11 - Van der Heide A, Jacobs JW, Bijlsma JW, Heurkens AH, van Booma-Frankfort C, van der Veen MJ et al. The Effectiveness of Early Treatment with "Second-Line" Antirheumatic Drugs. A Randomized Controlled-Trial. Ann. Intern. Med. 1996; 124: 699-707.

Tab 12 - Van Jaarsveld CH, Jacobs JW, van der Veen MJ, Blaauw AA, Kruize AA, Hofman DM et al, on behalf of the Rheumatic Research Foundation Utrecht, The Netherlands. Aggressive treatment in early rheumatoid arthritis: a randomised controlled trial. Ann. Rheum. Dis. 2000; 59: 468-77.

Tab 13 - Landewe RB, Boers M, Verhoeven AC, Westhovens R, van de Laar MA, Markusse HM, et al. COBRA Combination Therapy in Patients with Early Rheumatoid Arthritis: Long-Term Structural Benefits of a Brief Intervention. Arthritis Rheum 2002; 46 (2): 347-356.

Tab 14 - Smolen JS, Kalden JR, Scott DL, Rozman B, Kvien TK, Larsen A, Loew-Friedrich I, Oed C, Rosenburg R, and the European Leflunomide Study group. Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoid arthritis: a double-blind, randomised, multicentre trial. The Lancet 1999; 353: 259-266.

Tab 15 - Strand V, Cohen S, Schiff M, Weaver A, Fleischmann R, Cannon G, Fox R, Moreland L, Olsen N, Furst D, Caldwell J, Kaine J, Sharp J, Hurley F, Loew-Friedrich I, for the Leflunomide Rheumatoid Arthritis Investigators group. Treatment of Active Rheumatoid Arthritis With Leflunomide Compared With Placebo and Methotrexate. Arch. Intern. Med. 1999; 159: 2542-2550.

Tab 16 - Strand V. Counterpoint from the trenches: a pragmatic approach to therapeutic trials in rheumatoid arthritis. Arthritis & Rheumatism 2004.