A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust

• Conditions: Rheumatoid Arthritis; MedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2006-004834-33-BE
• Lead Sponsor: OxyPharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-21
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. = 18 years old
2. Diagnosed with RA based on the ARA 1987 revised criteria
at least 16 weeks prior to study enrolment, Day 0 (Appendix B)
3. Have an ACR global functional status class of 1 to 3
(Appendix C)
4. Have active disease, defined as the presence of 6 swollen
joints and 6 tender joints in a 44 joint examination
5. Have a CRP level at screening of = 1.5 mg/dL
6. Have been taking oral or parenteral methotrexate (15 mg
weekly or above), have been using methotrexate for at least
16 weeks (up to Day 0 of study), and have been on a stable dose
for at least 8 weeks, up to Day 0. (Subjects using 10 to 15 mg
methotrexate may be considered for inclusion if an unacceptable
toxicity was recorded when higher doses were used.)
7. Stable optional RA medication:
- Folic acid supplementation if already in use
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
including cyclooxengase-2 (Cox-2) inhibitors – doses
must be stable for 4 weeks prior to dosing with study
drug and consistent with labelling recommendations
- Acetylsalicylic acid is allowed in low doses as
cardiovascular prophylaxis
- Oral glucocorticoids, daily doses of up to 10 mg (incl.) of
prednisolone or equivalent for 4 weeks prior to study
enrolment (Day 0)
- Painkillers (acetaminophen, Tramadol and similar, alone
or in combinations) usage as per routine instructions will
be allowed, except for 24 hours before rheumatology
evaluations
8. Are using adequate forms of birth control - defined as 2
methods of birth control (eg, contraceptives and single-barrier
methods). Birth control is not necessary in subjects who have
been postmenopausal for > 1 year or who are surgically sterile
(including hysterectomy)
9. Subjects must be able to give informed consent after reading
and understanding the subject information sheet, are willing to
comply with all study procedures including completing all
questionnaires.

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

1. Arthritis onset prior to 16 years old
2. Any of the following infections:
- Known or acute infection that may affect CRP levels
- Active tuberculosis
- Known chronic infection with human immunodeficiency
virus (HIV), hepatitis C virus (HCV) or hepatitis B virus
(HBV) including positive serology
3. Ongoing systemic inflammatory condition which may
interfere with the results of clinical or laboratory tests planned in
the study (eg, systemic lupus erythematosus or any other systemic
rheumatic disease other than RA)
4. Any clinically significant concurrent medical condition
resulting in the following abnormal laboratory values:
- Hepatic
• aspartate aminotransferase (AST) = 2× the upper
limit of normal (ULN)
• alanine aminotransferase (ALT) = 2× ULN
• Alkaline phosphatase = 2.5 × ULN
• Total bilirubin > ULN
- Renal
• Serum creatinine > 1.5 × ULN
• Urea > 1.5 × ULN
• Significant proteinuria (2+ on urinary dipstick test)
- Haematology­­
• Haemoglobin < 9 g/dL
• Leukocytes < 3.5 × 10exp6/dL
• Absolute neutrophil count (ANC) < 1.5 × 10exp9/L
• Platelets < 100 × 10exp6/L
5. Present or previous malignancies, except cured squamous or
basal skin cell carcinoma
6. Have uncontrolled diabetes mellitus
7. Have any medical condition, which in the judgment of the
Investigator, will put the subject at an unacceptable risk by
participating in the study
8. Require one or several of the following medications:
- Narcotics (except for Tramadol) or any drug for
treatment of RA other than NSAIDs, Cox-2 inhibitors,
acetaminophen/paracetamol for pain and arthritis control,
or aspirin (except for cardiovascular prophylaxis)
- Current or previous use of anti-inflammatory or immunemodulatory
therapy for treatment of RA (e.g., anti-IL-1
and anti-B-cell treatment)
- Current or previous use of DMARDs (e.g.
sulphasalazine, antimalarials, etc.), except methotrexate,
within 4 months prior to study enrolment (Day 0)
- Anti-tumour necrosis factor [anti-TNF] 2 months prior to
study enrolment (Day 0)
- Intra-articular, intramuscular, or intravenous
glucocorticoids within 4 weeks prior to study enrolment
(Day 0)
9. Participation in an investigational study within the last 30
days or expects to be treated with an investigational product
during this study period.
10. Current or recent history (within 12 months of screening) of
drug or substance abuse, including alcohol
11. Females who are pregnant or nursing
12. Have any clinically significant abnormality on physical
examination, laboratory testing, vital signs, or 12-lead ECG
suggestive of a significant unstable medical condition
13. Have any other condition that in the opinion of the
Investigator, could interfere with the subject’s study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified