M06.9
Conditions
Interventions
Group 1: Anthroposophic integrative therapy -
1) No DMARD
2) No synovectomy (chemical, radiation or surgical). Intraarticular corticosteroid injections to be avoided as far as possible
3) Corticosteroids in cases with moderate systemic inflammatory activity or visceral organ affection (initial dose according to inflammatory activity [0.3-1.5 mg/kg prednisolone equivalents daily], sl
4) NSAID as needed (dosage according to manufacturers' recommendations)
5) Conventional physical therapy (exercises, heat and cold applications, massage, balneotherapy) as needed
6) Inpatient treatment (in cases of acute exacerbations or complications)
7) Anthroposophic medications, selected from a pre-defined medication list: oral, cutaneous or subcutaneous (not intra-articular) application
8) Anthroposophic nonmedication therapy: eurythmy therapy, art therapy (painting, clay modelling or speech exercises)
9) Special anthroposophic physical treatment modalities (compresses, oil dispersion baths, rhythmic embrocation)
10) Detailed biographical anamnesis followed by biographical counselling by the physician
11) Nutrition counselling
12) Over 4 years, every 3 months all participants are examined by a physician, fill in questionnaires and blood tests are taken
each year the hands and feet are examined by x-ray.
Group 2: Conventional therapy -
1) At least one DMARD mandatory: methotrexate, sulfasalazine, gold prep. i.m., chloroquine, azathioprine, cyclospo
2) Invasive joint therapy (chemical, radiation or surgical synovectomy, intraarticular corticosteroi
Sponsors
FilderklinikGemeinnütziges Gemeinschaftskrankenhaus
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis according to the 1987 American College of Rheumatology criteria. Independent confirmation of diagnosis by experienced rheumatologist.
Exclusion criteria
Exclusion criteria: [1] Disease duration > 3 years since onset of initial symptoms (painful swelling of RA-typical joints or tenosynovitis of the hands; [2] other rheumatic disorders; [3] previous treatment with disease modifying anti rheumatic drugs (DMARDs); [4] high-dose iv. corticosteroids or intraarticular corticosteroid injections in the past six weeks [5] radiological or medical synovectomy in the past six weeks; [6] previous surgical synovectomy; [7] severe concomitant disorders (e.g. malignant disease, severe hepatic disease, renal insufficiency); [8] substance abuse (alcohol, drugs or chemicals), mental disorders; [9] conditions that could mimic RA (e.g. acute infections, osteomalacia, neurological diseases); [10] personality disorders or life circumstances with increased risk of lack of cooperation during the study; [11] current pregnancy or puerperium; [12] participation in another clinical study of rheumatoid arthritis during follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcomes [1-3]: [1] Intensity of RA symptoms and signs (0-400) by patient self-rating, sum of four visual analogue scales (each 0-100): joint inflammation in past 3 months, joint swelling today, joint pain today, joint stiffness today. Measurement time points: every 3 month between months 0 and 48. Primary analysis: Area Under the Curve according to trapezoidal rule: Change from months 0-3-6-9 to months 39-42-45-48; [2] C-Reactive Protein in serum. Measurement time points: every 3 month between months 0 and 48. Primary analysis: Area under the Curve according to trapezoidal rule: Change from months 0-3-6-9 to months 39-42-45-48; [3] Radiological signs of joint destruction in hands and feet: Ratingen-Score. Measurement time points: Months 0, 12, 24, 36, and 48. Primary analysis: Change from month 0 to month 48. Primary safety outcomes [4-6]: [4] Withdrawals from the study protocol. Measurement time points: every 3 month between months 0 and 48. Primary analysis: incidence in months 0-48; [5] Serious Adverse Events, defined according to GCP-ICH guidelines. Measurement time points: continuous between months 0 and 48. Primary analysis: incidence in months 0-48; [6] Adverse Drug Reactions, defined according to GCP-ICH guidelines. Measurement time points: every 3 month between months 0 and 48. Primary analysis: incidence in months 0-48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician documentation - [1] Steinbrocker radiological staging system (0-4); [2] Steinbrocker Functional Classification (I-IV); [3] Number of swollen joints (0-40); [4] Ritchie Index, joint tenderness (0-78); [5] Number of Pinals remission criteria fulfilled (0-6); [6] Grip strength of right hand (mbar); [7] Grip strength of left hand (mbar); [8] Therapy efficacy rating (VAS, 0-100); [9] Therapy tolerability rating (VAS, 0-100); [10] Disease Activity Score (van der Heijde); Laboratory - [11] Erythrocyte sedimentation rate (mm/h); Patient documentation - [12] Joint Pain Score (adapted from RADAR [Rapid Assessment of Disease Activity in Rheumatology] questionnaire); [13] Hanover Functional Ability Questionnaire (Kohlmann & Raspe); [14] Self-rating of current health status (VAS, 0-100); [15] Satisfaction with current health status (VAS, 0-100); [16] Therapy efficacy rating (1= poor, 2 = average, 3= good); [17] Therapy tolerability rating (1= poor, 2 = average, 3= good); [18] Use of corticosteroids (use yes/no, average daily dose in users); [19] Use of NSAID (use yes/no, average daily dose in users); [20] SF-12 Health Survey; [21] Self-defined therapy goals (unpublished questionnaire, Simon & Mau); [22] Pain Coping (German: Fragebogen zum Schmerzverhalten, Hoppe); [23] Disease Coping (German: Freiburger Fragebogen zur Krankheitsbewältigung, Muthny, FKV-LIS SE); [24] Questionnaire of locus of control (German: Fragebogen zur Erhebung von Kontrollüberzeugungen zu Krankheit und Gesundheit, Lohaus & Schmidt, KKG; [25] State and Trait Anxiety Inventory (Spielberger, STAI-G); [26] Self-Rating Depression Scale (Zung); Measurement time points: Every 3 months [2-17], every 12 months [1, 20-26], daily [18-19] | — |
Countries
Germany
Contacts
Public ContactAnja Glockmann
Institut für angewandte Erkenntnistheorie und medizinische Methodologie - An-Institut der Universität Witten/Herdecke
Outcome results
None listed