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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

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.

Condition or disease Intervention/treatment Phase
Progression of Rheumatoid Arthritis Drug: Prednisolone Drug: Placebo Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial
Actual Study Start Date : January 2014
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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.
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

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
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

Placebo Comparator: Placebo
daily oral tablet
Drug: Placebo



Primary Outcome Measures :
  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. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients in remission [ Time Frame: 12 weeks, 24 weeks, 52 weeks ]
  2. Changes of functional capacity [ Time Frame: Baseline, 12 weeks, 52 weeks ]
  3. Patient's assessment of disease activity [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 52 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000336


Locations
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Germany
Rheumatologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany, 33617
Rheumatologische Schwerpunktpraxis Bocholt
Bocholt, Germany, 46397
Rheumatologische Schwerpunktpraxis Bochum
Bochum, Germany, 44787
Rheumaticon Internistische Schwerpunktpraxis Immunologie, Rheumatologie, Osteologie JosefCarrée Bochum
Bochum, Germany, 44791
Rheumapraxis Dortmund
Dortmund, Germany, 44137
MVZ Dr. Kretzmann und Kollegen
Dortmund, Germany, 44147
Rheumatologische Schwerpunktpraxis Dortmund
Dortmund, Germany, 44263
Rheumapraxis Duisburg
Duisburg, Germany, 47057
Rheumapraxis Gelsenkirchen
Gelsenkirchen, Germany, 45891
Internistische und rheumatologische Praxis Gladbeck
Gladbeck, Germany, 45964
Facharztzentrum Hagen
Hagen, Germany, 58089
Orthopädisch-rheumatologische Schwerpunktpraxis
Hattingen, Germany, 45525
Rheumapraxis Hattingen
Hattingen, Germany, 45525
Rheumazentrum Ruhrgebiet
Herne, Germany, 44649
Rheumapraxis Herne
Herne, Germany, 44652
Rheumatologische Schwerpunktpraxis Lingen
Lingen, Germany, 49808
Rheumapraxis am EVK
Lippstadt, Germany, 59555
Rheumatologische Schwerpunktpraxis Marl
Marl, Germany, 45768
Rheumatologische Schwerpunktpraxis Minden
Minden, Germany, 32425
Rheumatologische Schwerpunktpraxis Münster
Münster, Germany, 48143
Rheumapraxis Oberhausen
Oberhausen, Germany, 46145
Rheumapraxis Paderborn
Paderborn, Germany, 33098
Rheumazentrum Ratingen
Ratingen, Germany, 40878
Rheumatologische Schwerpunktpraxis Rheine
Rheine, Germany, 48431
Rheumapraxis Warendorf
Warendorf, Germany, 48231
Sponsors and Collaborators
Prof. Dr. rer. nat. H.J. Trampisch
Ruhr University of Bochum
Investigators
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Principal Investigator: Juergen Braun, MD Rheumazentrum Ruhrgebiet, Herne/Germany

Publications:
Dachverband Osteologie e.V., DVO-Leitlinie 2009 zur Prophylaxe, Diagnostik und Therapie der Osteoporose bei Erwachsenen, Osteologie 4/2009: 304 -324.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. rer. nat. H.J. Trampisch, Professor Dr. rer.nat., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02000336     History of Changes
Other Study ID Numbers: 01KG1204
2012-004074-25 ( EudraCT Number )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by Prof. Dr. rer. nat. H.J. Trampisch, Ruhr University of Bochum:
radiographic damage
rheumatoid arthritis

Additional relevant MeSH terms:
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Connective Tissue Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents