Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis

NCT02000336 | Completed Phase 3 DMC

• 2 other identifiers: 01KG12042012-004074-25
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 25

Brief Summary

Although cortisone is widely used in the treatment of patients with early rheumatoid arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon starting dosages and placebo in the treatment of patients with early active rheumatoid arthritis on the background of the established therapy with methotrexate. In total 450 patients will be included into the study. Two different treatment arms starting with 10 or 60 mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel, all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy endpoint is progression of radiographic damage after one year compared to baseline. Safety monitoring is performed.

Conditions

Progression of Rheumatoid Arthritis

Keywords

radiographic damage; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Progression of radiographic damage after one year as quantified by the van der Heijde modification of the Sharp score (SHS). Determined at baseline and after one year.

  15 sites in each hand and wrist and six joints in each foot are examined for joint space narrowing on a scale of 0 to 437: 0 indicates no narrowing, 1 represents minimal narrowing, 2 indicates loss of 50% of the joint space, 3 indicates loss of 75% of the joint space, and 4 represents complete loss of the joint space. The erosions are counted individually, usually at 16 sites in each hand and wrist and six sites in each foot, with a maximum score of 5 given for a destroyed hand or foot joint. For joints in the feet, the van der Heijde version of the Sharp scoring system has a maximum score of 10 for a destroyed joint

  52 weeks

Secondary Outcomes (3)

• Percentage of patients in remission

  12 weeks, 24 weeks, 52 weeks

• Changes of functional capacity

  Baseline, 12 weeks, 52 weeks

• Patient's assessment of disease activity

  Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 52 weeks

Study Arms (3)

Prednisolone 10

EXPERIMENTAL

Prednihexal (Prednisolon), daily oral tablet, 10 mg during week one to four, 7,5 mg during week five to eight. Finally 5 mg for four weeks.

Drug: Prednisolone

Prednisolone 60

EXPERIMENTAL

Prednihexal (Prednisolon), daily oral tablet, 60 mg during the first week, weekly tapering: 40 mg, 20mg, 15mg, 10mg, 7,5mg. 7,5mg continued for one more week. Finally 5 mg for four weeks

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

daily oral tablet

Drug: Placebo

Interventions

Prednisolone DRUG

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 (MTX).

Also known as: PredniHexal

Prednisolone 10; Prednisolone 60

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of rheumatoid arthritis based on expert opinion according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2009 criteria (Hawker 2009)
• disease duration \< 3 years
• active disease: disease activity score (DAS) 28 erythrocyte sedimentation rate (ESR) (Prevoo et al 1995) \> 4 plus ≥ 3 swollen joints

You may not qualify if:

• Prior treatment with disease-modifying antirheumatic drugs (DMARDs) (except for hydroxychloroquine 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,
• uncontrolled arterial hypertension,
• relevant immunodeficiency incl. HIV-infection,
• clinically significant pulmonary fibrosis,
• history of malignant melanoma,
• complicated or refractory gastrointestinal ulcers,
• presence or history of severe infections,
• uncontrolled increased intraocular pressure,
• pregnancy or planned pregnancy,

Sponsors & Collaborators

• Prof. Dr. rer. nat. H.J. Trampisch: lead
• Ruhr University of Bochum: collaborator

Study Sites (25)

Rheumatologische Schwerpunktpraxis Bielefeld

Bielefeld, 33617, Germany

Location

Rheumatologische Schwerpunktpraxis Bocholt

Bocholt, 46397, Germany

Location

Rheumatologische Schwerpunktpraxis Bochum

Bochum, 44787, Germany

Location

Rheumaticon Internistische Schwerpunktpraxis Immunologie, Rheumatologie, Osteologie JosefCarrée Bochum

Bochum, 44791, Germany

Location

Rheumapraxis Dortmund

Dortmund, 44137, Germany

Location

MVZ Dr. Kretzmann und Kollegen

Dortmund, 44147, Germany

Location

Rheumatologische Schwerpunktpraxis Dortmund

Dortmund, 44263, Germany

Location

Rheumapraxis Duisburg

Duisburg, 47057, Germany

Location

Rheumapraxis Gelsenkirchen

Gelsenkirchen, 45891, Germany

Location

Internistische und rheumatologische Praxis Gladbeck

Gladbeck, 45964, Germany

Location

Facharztzentrum Hagen

Hagen, 58089, Germany

Location

Orthopädisch-rheumatologische Schwerpunktpraxis

Hattingen, 45525, Germany

Location

Rheumapraxis Hattingen

Hattingen, 45525, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Rheumapraxis Herne

Herne, 44652, Germany

Location

Rheumatologische Schwerpunktpraxis Lingen

Lingen, 49808, Germany

Location

Rheumapraxis am EVK

Lippstadt, 59555, Germany

Location

Rheumatologische Schwerpunktpraxis Marl

Marl, 45768, Germany

Location

Rheumatologische Schwerpunktpraxis Minden

Minden, 32425, Germany

Location

Rheumatologische Schwerpunktpraxis Münster

Münster, 48143, Germany

Location

Rheumapraxis Oberhausen

Oberhausen, 46145, Germany

Location

Rheumapraxis Paderborn

Paderborn, 33098, Germany

Location

Rheumazentrum Ratingen

Ratingen, 40878, Germany

Location

Rheumatologische Schwerpunktpraxis Rheine

Rheine, 48431, Germany

Location

Rheumapraxis Warendorf

Warendorf, 48231, Germany

Location

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  BACKGROUND

• Trampisch US, Krause D, Trampisch HJ, Klaassen-Mielke R, Baraliakos X, Braun J. Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial. Trials. 2014 Sep 2;15:344. doi: 10.1186/1745-6215-15-344.

  PMID: 25181946 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Juergen Braun, MD

  Rheumazentrum Ruhrgebiet, Herne/Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. rer.nat.

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

DE (25)