Long-term effects of initial bridging therapy with prednisolone in the treatment of patients with early rheumatoid arthritis - a post-RCT observational study.

Long-term effects of initial bridging therapy with prednisolone in the treatment of patients with early rheumatoid arthritis - a post-RCT observational study. - CORRA-LOS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030294

Enrollment

240

Registered

2022-09-19

Start date

2018-02-17

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M05

Interventions

Group 1: Prednihexal (prednisolone), daily orally as a tablet, 60mg in the first week, each week dose reduction to: 40mg, 20mg, 15mg, 10mg, 7.5mg. 7.5mg continued for another week. Finally, 5 mg for f

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis of RA according to the ACR/EULAR 2010 criteria (Aletaha et al. 2010), - Duration of disease less than three years, - active disease: DAS 28 (ESR)> 4 and = 3 swollen joints (considered 40 joints) - Sufficient compliance regarding medication intake and attendance at examination appointments to be expected according to the physician's assessment, - legal capacity - Sufficient knowledge of German (to complete the questionnaires independently). - written consent to participate in the study.

Exclusion criteria

Exclusion criteria: - Age two times the upper normal limit), o Known hepatitis B or C infection, o CreatinineClearance< 30 ml/minute, o clinically relevant hematologic disease, o uncontrollable diabetes mellitus, o uncontrollable arterial hypertension o relevant immunodeficiency including HIV infection, o clinically significant pulmonary fibrosis, o history of malignant melanoma, o uncontrollable intraocular pressure elevation. o no sufficient compliance

Design outcomes

Primary

Measure	Time frame
Progression of radiologically detectable damage at the fifth year after treatment initiation measured with the van der Heijde modification of the Sharp score (SHS). Measurement time points: 3 and 5 years after treatment initiation.	—

Secondary

Measure	Time frame
Secondary endpoints include the proportion of patients in remission, the change in functional capacity during the observation period, the proportion of patients on biologics, and several near-patient outcome parameters.	—

Countries

Germany

Contacts

Public ContactAnna Mai

Ruhr-Universität Bochum, Abteilung für medizinische Informatik, Biometrie und Epidemiologie

mai@amib.rub.de+49234-32-27918

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026