Ruediger Mueller - Clinical Trials in Rheumatology
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Trial | Pulsed methylprednisolone in active early rheumatoid disease: a dose-ranging study |
Substance | 1 methylprednisolone 40 mg (n = 24) 1 methylprednisolone 500 mg (n = 22) 1 methylprednisolone 1g were (n = 23) Concomitant medication: No information provided Previous medication: No DMARD 6 months No oral corticosteroidsw 6 months |
Result | Single doses of methylprednisolone below 1g were not helpful in the management of acute RA |
Patients | 71 patients with active classical or definite RA Deemed by the clinician to warrant second line treatment Disease duration < 5 years |
Authors | Shipley ME, Bacon PA, Berry H, Hazleman BL, Sturrock RD, Swinson DR, Williams IA |
Publication | Br J Rheumatol . 1988 Jun;27(3):211214 |
Follow up | 9 weeks |
Note | Patient did benefit from treatment n = 10 (40 mg), n = 13 (500 mg), n = 20 (1g) Complete trial n = 9 (40 mg), n = 7 (500 mg), n = 16 (1g) |
Adverse events | Total number of adverse events n = 15 (40 mg), n = 20 (500 mg), n = 32 (1g) |
Trial | Intravenous pulsed steroids in rheumatoid arthritis: a comparative dose study |
Substance | 3 100 mg methylprednisolone (n = 17) 3 1,000 mg methylprednisolone (n = 19) Concomitant medication: DMARDs were permitted at the rheumatologists discretion Previous medication: DMARDs NSAIDs Oral corticosteroids 420 mg/day |
Result | Treatment of RA flares with 3 100 mg methylprednisolone was as efficacious as conventional 1,000 mg methylprednisolone pulses |
Patients | 36 patients with RA synovitis flares Judged by the rheumatologist to require pulse steroids |
Authors | Iglehart IW 3rd, Sutton JD, Bender JC, Shaw RA, Ziminski CM, Holt PA, Hochberg MC, Zizic TM, Engle EW, Stevens MB |
Publication | J Rheumatol . 1990 Feb;17(2):159162 |
Follow up | 3 months |
Note | Change of: Subjective disease activity (VAS 04) -2 (100 mg), -1 (1,000 mg) Pain VAS (017) -3 (100 mg), -6 (1,000 mg) Tender joint count -8 (100 mg), -9 (1,000 mg) Swollen joint count -17 (100 mg), -12 (1,000 mg) Morning stiffness -0.5 h (100 mg), -2.37 h (1,000 mg) Grip strength +25 mmHg (100 mg), +23 mmHg (1,000 mg) 50 m walking time -8 s (100 mg), -9 s (1,000 mg) ESR -9 mm/h (100 mg), -11 mm/h (1,000 mg) New DMARDs within 1st month n = 4 (100 mg), n = 8 (1,000 mg) |
Trial | Oral steroids as bridge therapy in rheumatoid arthritis patients starting with parenteral gold. A randomized double-blind placebo-controlled trial |
Substance | 10 mg prednisone/day for 12 weeks 7.5 mg prednisone/day (weeks 13, 14) 5 mg prednisone/day (weeks 15, 16) 2.5 mg prednisone/day (weeks 17, 18, n = 20) Placebo (n = 20) Concomitant medication: 10 mg aurothioglucose (first week) 50 mg aurothioglucose/week (until week 20) 50 mg aurothioglucose/24 weeks NSAIDs were permitted DMARDs were permitted at the rheumatologists discretion Previous medication : DMARD Corticosteroids |
Result | Oral prednisone (10 mg/day) reduced short-term disease activity in 60% of patients with active RA. After tapering the dose a rebound deterioration occurred |
Patients | 40 patients starting aurothioglucose Patients failed DMARD therapy 3 out of: 5 tender joints 3 swollen joints Morning stiffness 60 min ESR > 28 mm/h Hemoglobulin below normal limits |
Authors | van Gestel AM, Laan RF, Haagsma CJ, van de Putte LB, van Riel PL |
Publication | Br J Rheumatol . 1995 Apr;34(4):347351 |
Follow up | 44 weeks |
Note | Decrease of DAS > 1.08: Week 1 n = 8 (gold + prednisone), n = 0 (gold) Week 2 n = 8 (gold + prednisone), n = 0 (gold) Week 4 n = 12 (gold + prednisone), n = 0 (gold) Week 8 n = 14 (gold + prednisone), n = 4 (gold) Week 12 n = 13 (gold + prednisone), n = 8 (gold) Week 16 n = 13 (gold + prednisone), n = 8 (gold) Week 20 n = 7 (gold + prednisone), n = 13 (gold) Week 24 n = 7 (gold + prednisone), n = 12 (gold) Week 28 n = 11 (gold + prednisone), n = 12 (gold) Week 32 n = 11 (gold + prednisone), n = 8 (gold) Week 36 n = 13 (gold + prednisone), n = 7 (gold) Week 40 n = 12 (gold + prednisone), n = 11 (gold) Week 44 n = 14 (gold + prednisone), n = 13 (gold) Joint erosions (median) 3.5 (gold + prednisone), 5.0 (gold) Joint space narrowing (median) 2.0 (gold + prednisone), 2.0 (gold) Total joint damage (median) 4.5 (gold + prednisone), 7.0 (gold) |
Title | Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects: a randomized, double-blind, placebo-controlled clinical trial |
Substance | 10 mg of oral prednisone/day (n = 41) Placebo (n = 40) After 6 months: 2 g sulfasalazine/day as rescue medication Concomitant medication: NSAIDs were allowed in both groups 500 mg calcium Local glucocorticoid injections were permitted Physical therapy was permitted Additional use of paracetamol was permitted Previous medication: No cytotoxic or immunosuppressive drugs |
Result | 10 mg Prednisone/day in patients with early active rheumatoid arthritis was clinically beneficial, particularly in the first 6 months. It substantially inhibited progression of radiologic joint damage |
Patients | 81 patients with early active, untreated rheumatoid arthritis disease Disease duration < 1year Morning stiffness 30 min Joint tenderness and swelling 3 joints ESR 28 mm/h |
Authors | van Everdingen AA, Jacobs JW, Siewertsz Van Reesema DR, Bijlsma JW |
Publication | Ann Intern Med . 2002 Jan 1;136(1):112 |
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