A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004399-38-EE

Enrollment

616

Registered

2008-02-29

Start date

2008-04-18

Completion date

Unknown

Last updated

2012-06-26

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

Conditions

RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Interventions

Product Code: CRx-102 Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.9 and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, candidates must meet the following inclusion criteria: • I01 Subject must voluntarily give written informed consent • I02 Subject must complete Protocol CRx-102-007 without having discontinued study drug prematurely for any reason • I03 Subject must be willing to continue to take a multivitamin or at least 400 IU vitamin D daily and at least the equivalent of 1000 mg of elemental calcium daily. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects will be excluded from study entry if the following exclusion criterion are met: • E01 Subject had major protocol violation(s) in Protocol CRx-102007 • E02 The anticipated need for any of the following medications over the 1-year duration of the study: -Anticoagulants e.g., dipyridamole, warfarin, clopidogrel, ticlopidine, or acetylsalicylic acid (ASA; aspirin) > 150 mg per day -Oral steroids • E03 Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the subject unsuitable for the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of CRx-102 in subjects with active rheumatoid arthritis (RA) over 1 year To assess the effectiveness of CRx-102 in subjects with active RA over 1 year ;Secondary Objective: NA;Primary end point(s): Efficacy endpoints are to assess the long-term effectiveness of 2 different doses of CRx-102 in subjects with active RA using the following measurements: • American College of Rheumatology rating scale 20%, 50%, and 70% or more improvement (ACR 20, ACR 50, ACR 70) • Joint space narrowing, erosions, and total Sharp score (by hand x-ray) • DAS28 • C-Reactive protein (CRP) levels Safety endpoints are: Adverse Events, Clinically significant changes from baseline in observed by physical examinations including eye examination and IOP, vital signs, ECG, laboratory parameters including CBC with differential and platelet counts, serum chemistry panels, lipid panels, HgbA1c, ACTH stimulation testing, and urinalysis, DEXA scans, and concomitant medications. Bone biomarkers will be collected in the subset of subjects in North America and Poland.	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of CRx-102 in subjects with active rheumatoid arthritis (RA) over 1 year To assess the effectiveness of CRx-102 in subjects with active RA over 1 year ;Secondary Objective: NA;Primary end point(s): Efficacy endpoints are to assess the long-term effectiveness of 2 different doses of CRx-102 in subjects with active RA using the following measurements: • American College of Rheumatology rating scale 20%, 50%, and 70% or more improvement (ACR 20, ACR 50, ACR 70) • Joint space narrowing, erosions, and total Sharp score (by hand x-ray) • DAS28 • C-Reactive protein (CRP) levels Safety endpoints are: Adverse Events, Clinically significant changes from baseline in observed by physical examinations including eye examination and IOP, vital signs, ECG, laboratory parameters including CBC with differential and platelet counts, serum chemistry panels, lipid panels, HgbA1c, ACTH stimulation testing, and urinalysis, DEXA scans, and concomitant medications. Bone biomarkers will be collected in the subset of subjects in North America and Poland.

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Countries

Estonia, Lithuania, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026