Rudiger Muller - Clinical Trials in Rheumatology
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- Book:Clinical Trials in Rheumatology
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- Year:2012
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Clinical Trials in Rheumatology: summary, description and annotation
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A huge number of therapeutic studies has been published in rheumatology and clinical immunology. This number grows substantially by the year. As such, it becomes increasingly difficult to keep track of this multitude of studies and the ensuing therapeutic trends. Further to this, a particular study can be referred to in a variety of ways, either as a shortened version of the title or an acronym, adding to the confusion. The book Clinical Trials in Rheumatology, Second Edition, provides an updated summary of the important studies in the field for easy reference. Every study is shown with name, acronym (if in existence), authors, complete citation, study design, and a short overview of the trials data and main conclusions. An acronym finder is supplied at the beginning of the book. This book is a valuable reference tool for rheumatologists and other clinical specialties, as well as for research scientists interested in immunomodulatory and selected other drug therapies in rheumatologic diseases.
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Trial | Pulsed methylprednisolone in active early rheumatoid disease: a dose-ranging study | ||
|---|---|---|---|
Substance | Methylprednisolone 140 mg ( n =24) | ||
Methylprednisolone 1500 mg ( n =22) | |||
Methylprednisolone 11 g ( n =23) | |||
Concomitant medication : | |||
No information provided | |||
Previous medication : | |||
No DMARD 6 months | |||
No oral corticosteroids 6 months | |||
Result | Single doses of methylprednisolone below 1 g 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 and Williams IA | ||
Publication | Br J Rheumatol . 1988 Jun;27(3):211214 | ||
Follow-up | 9 weeks | ||
Note | MP 40 mg | MP 500 mg | MP 1 g |
Patient did benefit from treatment | n =10 | n =13 | n =20 |
Complete trial | n =9 | n =7 | n =16 |
Adverse events | b | MP 500 mg | MP 1 g |
Total number of adverse events | n =15 | n =20 | n =32 |
Trial | Intravenous pulsed steroids in rheumatoid arthritis: a comparative dose study | |
|---|---|---|
Substance | Methylprednisolone 3100 mg ( n =17) | |
Methylprednisolone 31,000 mg ( 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 3100 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 and Stevens MB | |
Publication | J Rheumatol . 1990 Feb;17(2):159162 | |
Follow-up | 3 months | |
Note | Change of : | |
MP 100 mg | MP 1,000 mg | |
Subjective disease activity (VAS 04) | ||
Pain VAS (017) | ||
Tender joint count | ||
Swollen joint count | ||
Morning stiffness | 0.5 h | 2.37 h |
Grip strength (mmHg) | +25 | +23 |
50-m walking time | 8 s | 9 s |
ESR | 9 mm/h | 11 mm/h |
New DMARDs within first month | n =4 | n =8 |
Trial | Oral steroids as bridge therapy in rheumatoid arthritis patients starting with parenteral gold. A randomized double-blind placebo-controlled trial | |
|---|---|---|
Substance | Prednisone 10 mg/day for 12 weeks | |
Prednisone 7.5 mg/day (weeks 13, 14) | ||
Prednisone 5 mg/day (weeks 15, 16) | ||
Prednisone 2.5 mg/day (weeks 17, 18, n =20) | ||
Placebo ( n =20) | ||
Concomitant medication : | ||
Aurothioglucose 10 mg (first week) | ||
Aurothioglucose 50 mg/week (until week 20) | ||
Aurothioglucose 50 mg/24 weeks | ||
NSAIDs were permitted | ||
DMARDs were permitted at the rheumatologists discretion | ||
Previous medication : | ||
DMARD | ||
Corticosteroids | ||
Result | Oral prednisone reduced short-term disease activity in the majority of patients with active RA. After tapering the dose rebound deterioration occurred | |
Patients | 40 patients starting aurothioglucose | |
Patients who failed DMARD therapy | ||
3 out of the following : | ||
5 Tender joints | ||
3 Swollen joints | ||
Morning stiffness for 60 min | ||
ESR >28 mm/h | ||
Hemoglobin below normal limits | ||
Authors | van Gestel AM, Laan RF, Haagsma CJ, van de Putte LB and van Riel PL | |
Publication | Br J Rheumatol . 1995 Apr;34(4):347351 | |
Follow-up | 44 weeks | |
Note | Decrease of DAS >1.08 : | |
Gold+prednisone | Gold | |
Week 1 | n =8 | n =0 |
Week 2 | n =8 | n =0 |
Week 4 | n =12 | n =0 |
Week 8 | n =14 | n =4 |
Week 12 | n =13 | n =8 |
Week 16 | n =13 | n =8 |
Week 20 | n =7 | n =13 |
Week 24 | n =7 | n =12 |
Week 28 | n =11 | n =12 |
Week 32 | n =11 | n =8 |
Week 36 | n =13 | n =7 |
Week 40 | n =12 | n =11 |
Week 44 | n =14 | n =13 |
Joint erosions (median) | 3.5 |
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