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Trial record 17 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

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

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ClinicalTrials.gov Identifier: NCT02000336
Recruitment Status : Active, not recruiting
First Posted : December 4, 2013
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Ruhr University of Bochum
Information provided by (Responsible Party):
Prof. Dr. rer. nat. H.J. Trampisch, Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE December 4, 2013
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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. [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02000336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Percentage of patients in remission [ Time Frame: 12 weeks, 24 weeks, 52 weeks ]
  • Changes of functional capacity [ Time Frame: Baseline, 12 weeks, 52 weeks ]
  • Patient's assessment of disease activity [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis
Official Title  ICMJE Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial
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.
Detailed Description

BACKGROUND: Although glucocorticoids (GCs) are widely used in the treatment of patients with early rheumatoid arthritis (RA), the best dosage for GCs, related to both, efficacy and safety, is not known.

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 (MTX).

METHODS: Randomised double-blind placebo-controlled trial with two treatment arms (starting with 10 or 60 mg of p.o. prednisolone (P), tapered down to 5 mg P per day within 8 weeks) and one placebo arm, each arm comprising 150 patients. Duration of intervention is 12 weeks. In parallel, all patients start medication with MTX, usual dosage 15 mg/week. Primary efficacy endpoint is progression of radiographic damage after one year compared to baseline. Secondary endpoints are: percentage of patients in remission, changes of functional capacity etc. Safety monitoring is performed.

The analysis is performed in three hierarchical steps. First step is an analysis of covariance to compare the group with an initial P dosage of 60 mg (V60) and the placebo group (Pl). In case of a statistical significant result (α = 0.05), a comparison of the group starting with 10 mg P (V10) and Pl will be done in a second step (α = 0.05). In case of superiority of V10 versus Pl, a third step will be a non-inferiority test for V10 versus V60 (α = 0.025).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Progression of Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Prednisolone
    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).
    Other Name: PredniHexal
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Prednisolone 10
    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.
    Intervention: Drug: Prednisolone
  • Experimental: Prednisolone 60
    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
    Intervention: Drug: Prednisolone
  • Placebo Comparator: Placebo
    daily oral tablet
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
386
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
450
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • non-compliance,
  • age < 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000336
Other Study ID Numbers  ICMJE 01KG1204
2012-004074-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. rer. nat. H.J. Trampisch, Ruhr University of Bochum
Study Sponsor  ICMJE Prof. Dr. rer. nat. H.J. Trampisch
Collaborators  ICMJE Ruhr University of Bochum
Investigators  ICMJE
Principal Investigator: Juergen Braun, MD Rheumazentrum Ruhrgebiet, Herne/Germany
PRS Account Ruhr University of Bochum
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP