Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis

Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004074-25-DE

Enrollment

450

Registered

2013-07-29

Start date

2013-10-30

Completion date

Unknown

Last updated

2018-07-23

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

Conditions

Early rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of rheumatoid arthritis based on expert opinion according to the ACR/EULAR 2009 criteria (Hawker 2009), disease duration 4 plus = 3 swollen joints Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 225

Exclusion criteria

Exclusion criteria: Prior treatment with DMARDs (except for hydroxychloroquin or sulfasalazine or methotrexate during the last four weeks before screening) Clinically relevant comorbidity: concurrent liver disease (ALT > 2 times upper limit of normal), active hepatitis B or C viral infection, renal disease (creatinine clearance < 30 ml/minute), clinically relevant haematological disease due to the judgement of the rheumatologist, uncontrolled diabetes mellitus, relevant immunodeficiency incl. HIV-infection, clinically significant pulmonary fibrosis, presence or history of severe infections, pregnancy or planned pregnancy, non-compliance, age < 18 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare two standard p.o. GC starting dosages and the non-use of GCs in the treatment of patients with early active RA on the background of the established ‘anchor’ therapy with methotrexate;Secondary Objective: percentage of patients in remission, changes of functional capacity etc. Safety monitoring is performed;Primary end point(s): Progression of radiographic damage after one year compared to baseline (van der Heijde modification of the Sharp score);Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Main Objective: To compare two standard p.o. GC starting dosages and the non-use of GCs in the treatment of patients with early active RA on the background of the established ‘anchor’ therapy with methotrexate;Secondary Objective: percentage of patients in remission, changes of functional capacity etc. Safety monitoring is performed;Primary end point(s): Progression of radiographic damage after one year compared to baseline (van der Heijde modification of the Sharp score);Timepoint(s) of evaluation of this end point: 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): percentage of patients in remission, changes of functional capacity etc. Safety monitoring is performed;Timepoint(s) of evaluation of this end point: 12 weeks 24 weeks 52 weeks	—

Countries

Germany

Contacts

Public ContactClinical Trial Information

Abteilung für Medizinische Informatik, Biometrie und Epidemiologie

trampisch@amib.rub.de+492343227790

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 19, 2026