Recent clinical trials in the rheumatic diseases

Current Opinion in Rheumatology

Volumn 9, Issue 2, 1997, Pages 95-101

  Matteson, Eric L ^a  

^a MAYO CLINIC COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRHEUMATIC AGENT; COLLAGEN; COTRIMOXAZOLE; CYCLOOXYGENASE 2 INHIBITOR; IMMUNOGLOBULIN; LYMPHOCYTE ANTIBODY; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT;

ADJUVANT THERAPY; CLINICAL TRIAL; DRUG TOXICITY; HUMAN; INFECTION; META ANALYSIS; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RELAPSE; RHEUMATIC DISEASE; SHORT SURVEY; WEGENER GRANULOMATOSIS;

EID: 0030919364     PISSN: 10408711     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002281-199703000-00003     Document Type: Short Survey

References (49)

1. Fortin PR, Stucki G, Katz JN: Measuring relevant change: an emerging challenge in rheumatologic clinical trials. Arthritis Rheum 1995, 38:1027-1030.
2. Tubert-Bitter P, Bloch DA, Raynauld J-P: Comparing the bivarlate effects of toxicity and efficacy of treatments. Stat Med 1995, 14:1129-1141.
3. Boers M, Tugwell P, Felson DT, van Riel PL, Kirwan JR, Edmonds JP, Smolen JS, Khaltaev N, Muirden KD: World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol Suppl 1994, 41:86-89.
4. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, Katz LM, Lightfoot R Jr, Paulus H, Strand V, Tugwell P, Weinblatt M, Williams HJ, Wolfe F, Kieszak S: American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995, 38:727-735.
5. Strand V: Are there special considerations relevant to trials of biologic agents? J Rheumatol 1994, 21:41-45.
6. Strand V: Issues in clinical trials of biological agents. Baillieres Clin Rheumatol 1995, 9:825-835.
7. Ghozlan PR, Bernhardt M, Velicitat P, Bluhmki E: Tolerability of multiple administration of intramuscular meloxicam: a comparison with intramuscular piroxicam in patients with rheumatoid arthritis or osteoarthritis. Br J Rheumatol 1996, 1:51-55.
8. Hosie J, Distel M, Bluhmki E: Meloxicam in osteoarthritis: a 6-month, double-blind comparison with diclofenac sodium. Br J Rheumatol 1996, 1:39-43.
9. Martin-Mola E, Gijön-Baños J, Ansoleaga JJ: Aceclofenac in comparison to ketoprofen in the treatment of rheumatoid arthritis. Rheumatol Int 1995, 15:111-116.
10. O'Dell JR, Haire CE, Erikson N, Drymalsk W, Palmer W, Eckhoff PJ, Garwood V, Maloley P, Klassen LW, Wees S, Klein H, Moore GF: Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. N Engl J Med 1996, 334:1287-1291. A well-done important study suggesting benefit of combination therapy for rheumatoid arthritis.
11. McCarty DJ, Harman JG, Grassanovich JL, Qian C, Klein JP: Combination drug therapy of seropositive rheumatoid arthritis. J Rheumatol 1995 , 22:1636-1645.
12. Willkens RF, Sharp JT, Stablein D, Marks C, Wortmann R: Comparison of azathioprine, methotrexate, and the combination of the two in the treatment of rheumatoid arthritis. Arthritis Rheum 1995, 38:1799-1806.
13. Möttönen T, Paimela L, Ahonen J, Helve T, Hannonen P, Leirisalo-Repo M: Outcome in patients with early rheumatoid arthritis treated according to the "sawtooth" strategy. Arthritis Rheum 1996, 39:996-1005.
14. Fries JF: Reevaluating the therapeutic approach to rheumatoid arthritis: the "sawtooth" strategy. J Rheumatol 1990, 17:12-15.
15. Pasero G, Priolo F, Marubini E, Fantini F, Ferraccioli G, Magaro M, Marcolongo R, Oriente P, Pipitone V, Portioli I, Tirri G, Trotta F, Casa-Albenghi OD: Slow progression of joint damage in early rheumatoid arthritis treated with cyclosporin A. Arthritis Rheum 1996, 39:1006-1015.
16. ten Wolde S, Breedveld FC, Hermans J, Vandenbroucke JP, van de Laar MAFJ, Markusse HM, Janssen M, van den Brink HR, Dijkmans BAC: Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis. Lancet 1996, 347:347-352. This study demonstrated the efficacy of second-line drugs used in rheumatoid arthritits.
17. Drevlow BE, Lovis R, Haag MA, Sinacore JM, Jacobs C, Blosche C, Landay A, Moreland LW, Pope RM: Recombinant human interleukin-1 receptor type I in the treatment of patients with active rheumatoid arthritis. Arthritis Rheum 1996, 39:257-265.
18. Matteson EL, Yocum DE, St. Clair EW, Achkar AA, Thakor MS, Jacobs MR, Hays AE, Heitman CK, Johnston JM: Treatment of active refractory rheumatoid arthritis with humanized monoclonal antibody Campath-1H administered by daily subcutaneous injection. Arthritis Rheum 1995, 38:1187-1193.
19. Weinblatt ME, Maddison PJ, Bulpitt KJ, Hazleman BL, Urowitz MB, Sturrock RD, Coblyn JS, Maier AL, Spreen WR, Manna VK, Johnston JM: Campath-1H, a humanized monoclonal antibody, in refractory rheumatoid arthritis. Arthritis Rheum 1995, 38:1589-1594.
20. van der Lubbe PA, Dijkmans BAC, Markusse HM, Nässander U, Breedveld FC: A randomized, double-blind, placebo-controlled study of CD4 monoclonal antibody therapy in early rheumatoid arthritis. Arthritis Rheum 1995, 38:1097-1106.
21. Tak PP, van der Lubbe PA, Cauli A, Daha MR, Smeets TJM, Kluin PM, Meinders AE, Yanni G, Panayi GS, Breedveld FC: Reduction of synovial inflammation after anti-CD4 monoclonal antibody treatment in early rheumatoid arthritis. Arthritis Rheum 1995, 38:1457-1465.
22. Moreland LW, Pratt PW, Mayes MD, Postlethwaite A, Weisman MH, Schnitzer T, Lightfoot R, Calabrese L, Zelinger DJ, Woody JN, Koopman WJ: Double-blind, placebo-controlled multicenter trial using chimeric monoclonal anti-CD4 antibody, cM-T412, in rheumatoid arthritis patients receiving concomitant methotrexate. Arthritis Rheum 1995, 38:1581-1588. A well-done study demonstrating the lack of efficacy of this monoclonal antibody for rheumatoid arthritis.
23. Olsen NJ, Brooks RH, Cush JJ, Lipsky PE, St. Clair EW, Matteson EL, Gold KN, Cannon GW, Jackson CG, McCune WJ, Fox DA, The Xoma RA Investigator Group, Nelson B, Lorenz T, Strand V: A double-blind, placebo-controlled study of anti-CD5 immunoconjugate in patients with rheumatoid arthritis. Arthritis Rheum 1996, 39:1102-1108. A very large study in which the effect of this monoclonal antibody could not be demonstrated. Very large placebo effect was evident.
24. Lorenz H-M, Antoni C, Valerius T, Repp R, Grünke M, Schwerdtner N, NüBlein H, Woody J, Kalden JR, Manger B: In vivo blockade of TNF-α by intravenous infusion of a chimeric monoclonal TNF-α antibody in patients with rheumatoid arthritis. J Immunol 1996, 156:1646-1653.
25. Elliott MJ, Maini RN, Feldmann M, Kalden JR, Antoni C, Smolen JS, Leeb B, Breedveldt FC, Macfarlane JD, Biji H, Woody JN: Randomised double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor α (cA2) versus placebo in rheumatoid arthritis. Lancet 1994, 344:1105-1110.
26. Sieper J, Kary S, Sörensen H, Alten R, Eggens U, Huge W, Hiepe F, Kühne A, Listing J, Ulbrich N, Braun J, Zink A, Mitchison NA: Oral type II collagen treatment in early rheumatoid arthritis. Arthritis Rheum 1996, 39:41-51. This is an interesting study of benign therapy for rheumatoid arthritis. The efficcacy of oral type II collagen remains to be established.
27. Barnett ML, Combitchi D, Trentham DE: A pilot trial of oral type II collagen in the treatment of juvenile rheumatoid arthritis. Arthritis Rheum 1996, 39:623-628. Oral type II collagen appeared to have some benefit in JRA, definitive studies are needed, however.
28. Mladenovic V, Domljan Z, Rozman B, Jajic I, Mihajlovic D, Dordevic J, Popovic M, Dimitrijevic M, Zivkovic M, Campion G, Musikic P, Löw Friedrich I, Oed C, Seifert H, Strand V: Safety and effectiveness of leflunomide in the treatment of patients with active rheumatoid arthritis. Arthritis Rheum 1995, 38:1595-1603. A large study of novel chemotherapeutic agent that shows promise for treatment for active rheumatoid arthritis.
29. Gravallese EM, Handel ML, Coblyn J, Anderson RJ, Sperling RI, Karlson EW, Maier A, Ruderman EM, Formelli F, Weinblatt ME: N-[4-hydroxyphenyl] retinamide in rheumatoid arthritis: a pilot study. Arthritis Rheum 1996, 39:1021-1026.
30. Kanik KS, Yarboro CH, Naparstek Y, Plotz PH, Wilder RL: Failure of low-dose intravenous immunoglobulin therapy to suppress disease activity in patients with treatment-refractory rheumatoid arthritis. Arthritis Rheum 1996, 39:1027-1029.
31. Farr M, Waterhouse L, Johnson AE, Kitas GD, Jubb RW, Bacon PA: A double-blind controlled study comparing sulphasalazine with placebo in rheumatoid factor (RF)-negative rheumatoid arthritis. Clin Rheumatol 1995, 14:531-536.
32. Giannini EH, Lovell DJ, Silverman ED, Sundel RP, Tague BL, Ruperto N: Intravenous immunoglobulin in the treatment of polyarticular juvenile rheumatoid arthritis: a phase I/II study. J Rheumatol 1996, 23:919-924. A preliminary study which, if confirmed, could establish JRA as one of the few indications in rheumatology for the use of intravenous gammaglobulin.
33. McMurray RW, Weidensaul D, Allen SH, Walker SE: Efficacy of bromocriptine in an open label therapeutic trial for systemic lupus erythematosus. J Rheumatol 1995, 22:2084-2091.
34. van Vollenhoven RF, Engleman EG, McGuire JL: Dehydro-epiandrosterone in systemic lupus erythematosus. Arthritis Rheum 1995, 38:1826-1831.
35. Cervera H, Jara LJ, Pizarro S, Enkerlin HL, Fernandez M, Medina F, Fraga A, Miranda JM: Danazol for systemic lupus erythematosus with refractory autoimmune thrombocytopenia or Evans' syndrome. J Rheumatol 1995, 22:1867-1871.
36. Becker BN, Fuchs H, Hakim R: Intravenous immune globulin in the treatment of patients with systemic lupus erythematosus and endstage renal disease. J Am Soc Nephrol 1995, 5:1745-1750.
37. Puddu P, De Pita O, Ruffelli M, Bellucci AM, Girardelli CR, Galeazzi M, Marcolongo R: Intravenous immunoglobulin therapy: modification of the immunofluorescence pattern in the skin of six patients with systemic lupus erythematosus. Arthritis Rheum 1996, 39:704-708.
38. Matteson EL, Shbeeb MI, McCarthy TG, Calamia KT, Mertz LE, Goronzy JJ: Pilot study of antithymocyte globulin in systemic sclerosis. Arthritis Rheum 1996, 39:1132-1137.
39. Wilson D, Edworthy SM, Hart DA, Fritzler MJ: The safety and efficacy of low-dose tissue plasminogen activator in the treatment of systemic sclerosis. J Dermatol 1995, 22:637-642.
40. Palmieri GMA, Sebes JI, Aelion JA, Moinuddin M, Ray MW, Wood GC, Leventhal MR: Treatment of calcinosis with diltiazem. Arthritis Rheum 1995, 38:1646-1654.
41. Stegeman CA, Tervaert JWC, De Jong PE, Kallenberg CGM, the Dutch Co-Trimoxazole Wegener Study Group: Trimethoprim-sulfamethoxazole (co-trimoxazole) for the prevention of relapses of Wegener's granulomatosis. N Engl J Med 1996, 335:16-20. An important study that evaluates trimethoprim-sulfamethoxazole in the prevention of relapse in Wegener's granulomatosis, based on a relatively large cohort of patients with this disease.
42. Richter C, Schnabel A, Csernok E, De Groot K, Reinhold-Keller E, Gross WL: Treatment of anti-neutrophil cytoplasmic antibody (ANCA) associated systemic vasculitis with high-dose intravenous immunoglobulin. Clin Exp Immunol 1995, 101:2-7.
43. Di Munno O, Imbimbo B, Mazzantini M, Milani S, Occhipinti G, Pasero G: Deflazacort versus methylprednisolone in polymyalgia rheumatica: clinical equivalence and relative anti-inflammatory potency of different treatment regimens. J Rheumatol 1995, 22:1492-1498.
44. Ferraccioli G, Salaffi F, De Vita S, Casatta L, Bartoli E: Methotrexate in polymyalgia rheumatica: preliminary results of an open, randomized Study. J Rheumatol 1996, 23:624-628.
45. Eibschutz B, Baird SM, Weisman MH, Amox DG, Spellman M, Piacquadio D, Carrera CJ, Carson DA: Oral 2-chlorodeoxyadenosine in psoriatic arthritis: a preliminary report Arthritis Rheum 1995, 38:1604-1609.
46. Bevis PJ, Bird HA, Lapham G: An open study to assess the safety and tolerability of meloxicam 15 mg in subjects with rheumatic disease and mild renal impairment Br J Rheumatol 1996, 1:56-60.
47. Carette S, Oakson G, Guimont C, Steriade M: Sleep electroencephalography and the clinical response to amitriptyline in patients with fibromyalgia. Arthritis Rheum 1995, 38:1211-1217.
48. Bennett RM, Burckhardt CS, Clark SR, O'Reilly CA, Wiens AN, Campbell SM: Group treatment of fibromyalgia: a 6 month outpatient program. J Rheumatol 1996, 23:521-528.
49. Pearl SJ, Lue F, MacLean AW, Heslegrave RJ, Reynolds WJ, Moldofsky H: The effects of bright light treatment on the symptoms of fibromyalgia. J Rheumatol 1996, 23:896-902.