A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexate

• Conditions: Active rheumatoid arthritis (RA), patients taking stable doses of methotrexate; MedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2006-002645-37-HU
• Lead Sponsor: Kémia, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1 Diagnosis of RA (based on the American Rheumatism Association 1987 revised criteria for the classification of RA). Patients with the American College of Rheumatology (ACR) Global Functional Status Classes I to III will be included
2 The patient’s primary diagnosis should be RA and should have no evidence
of any other autoimmune rheumatological condition or overlap syndrome (except sicca syndrome; acceptable only if secondary not primary to RA). The patient may have evidence of osteoarthritis in a joint, secondary to pre-existing rheumatoid disease or may have evidence of osteoarthritis in the spine or in the small joints of the hand, so long as the osteoarthritis does not interfere with the evaluation of the joints targeted for evaluation nor interfere with evaluation of pain and function related to the RA under study
3 Active disease, defined as the presence of at least 8 evaluable swollen joints (out of 44 assessed) and at least 8 evaluable joints tender to palpation (out of 53 assessed) in a joint examination. Evaluable joints are those capable of response to anti-inflammatory therapy
4 CRP =20 mg/L
5 Stable mandatory RA medication – all patients should be on the following drugs: Oral or subcutaneous methotrexate (7.5 to 20 mg weekly); dose stable for 6 weeks prior to receiving study drug and dose not anticipated to change during the study
6 Stable optional RA medication, if appropriate: Folic acid supplementation (1 mg/day or 5 mg/week), Nonsteroidal anti-inflammatory drugs (NSAIDs) or Cox-2 inhibitors – doses should be stable for at least 6 weeks prior to dosing with study drug and consistent with labelling recommendations. Only one analgesic drug will be allowed other than low dose aspirin for cardiovascular prophylaxis. Corticosteroids (no more than 10 mg of prednisolone or equivalent)- stable dose for at least 6 weeks prior to dosing with study drug
7 Adequate contraceptive measures must be taken by both sexes. For women of child-bearing potential, 2 methods of contraception (e.g. oral contraceptives and single barrier method or double barrier methods) must be used unless patient is > 1 year post-menopausal or has had sterilization or hysterectomy.
8 Age: 18 - 70 years
9 Body mass index (BMI): 18.0 - 30.0 kg/square metre, inclusive
10 Willing to abstain from alcohol throughout study
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 Onset of arthritis prior to age 16
2 Use of any other drug, including narcotics, other than; NSAIDs, Cox-2 inhibitors, paracetamol (acetaminophen), corticosteroids for control of pain and/or arthritis or aspirin for cardiovascular prophylaxis.
3 Use of parenteral anti-inflammatory or immune-modulatory treatment (except methotrexate) within four months before receiving study drug.
4 Receipt of intra-articular, intramuscular or intravenous corticosteroids within 6 weeks prior to receiving study drug
5 Known acute infection that may affect CRP levels or active TB, hepatitis (B, C or other) or HIV
6 Current systemic inflammatory condition which may confound CRP assay or other clinical or laboratory evaluations.
7 Clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following:
Hepatobiliary
-AST or ALT =1.5 times upper limit of normal (ULN), alkaline phosphatase=2.0 times ULN on 2 consecutive occasions, or
-total bilirubin > 80% of ULN for the central laboratory at any time prior to the baseline visit;
Renal
-serum creatinine > 115 µmol/L, or
-significant proteinuria =2+ on urinary dip test;
Haematology
-haemoglobin < 80g/L
-leukocytes < 3.5 x 10 9/L
-neutrophils < 1.5 x 10 9/L, or
-platelets < 100 x 10 9/L;
Laboratory teats may be repeated if necessary. Any abnormal values may be discussed with Kemia's medical Monitor before the patient is exluded.
8 Presence or history of malignancy, apart from stable, adequately treated local dermatological cancers.
9 Poorly controlled diabetes.
10 Significant blood loss or donation of blood (>500 mL) within 28 days before randomisation
11 Use of an investigational drug within 1 month of screening or longer if that drug is expected to have long-acting effects (e.g., modulation of B-cell activity)
12 Current or recent history (within 12 months from screening) of drug or substance abuse, including alcohol
13 Known or suspected pregnancy; nursing mothers
14 Clinically significant abnormality on physical examination, laboratory testing, vital signs or electrocardiogram suggestive of significant unstable medical condition
15 Condition which, in the opinion of the investigator, could interfere with participation in the study or would put the patient at unacceptable risk.

Study & Design

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