Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis

• Conditions: Rheumatoid arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-022865-81-HU
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-15
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

For SAD and MAD:
1. Gender: male and female
2. Age: 18-80 years, inclusive
3. Body mass index (BMI): <35.0 kg/m2
4. Diagnosed with RA according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomization
5. Treatment with methotrexate (MTX) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period. Inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) (including MTX, where a patient may remain on treatment with MTX at a lower dose for improved tolerance, but with reduced effectiveness).
6. For patients (men and women) of reproductive potential, use of an acceptable method of contraception for the duration of the study. Female patients must be willing to use appropriate birth control measures that would prevent pregnancy starting from the time of signing the informed consent until 90 days after the last dose of study drug is administered
7. Ability and willingness to provide written informed consent and to comply with the protocol’s requirements

For SAD:
8. Disease Activity Score using 28 joint counts (DAS28) >= 2.4

For MAD:
8. DAS28 >= 3.2
9. Swollen joint count = 3

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 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. A documented history of an autoimmune disease other than RA (other than secondary Sjögren’s syndrome)
2. Functional class IV by ACR classification
3. Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061
4. Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray
5. Female patients who are pregnant during the study, or are breastfeeding
6. History of anaphylactic reactions to protein therapeutics
7. Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the SAD part of this study and who are eligible to participate in the MAD part
8. Donation of more than 300 mL of blood within 60 days prior to drug administration
9. Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ
10. Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study
11. Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalization for a clinically relevant event within the 4 weeks prior to screening
12. Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
13. Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
MAD part only:
14. Contraindication to MRIs or the use of contrast agents for MRI scanning, as determined by the Investigator and/or radiologist at the site’s MRI facility. Patients with potential contraindications to MRIs may include: patients who have a physical limitation related to fitting in the bore of the magnet (i.e. body weight > 115 kilograms); patients who have a history of allergic reaction to contrast agents; patients who have had exposure to a radiological contrast agent within 72 hours prior to the MRI examination; patients with implanted electronic devices (e.g. heart pacemaker), insulin pump, cochlear implants, neural stimulators, intracranial or other internal vascular clips or intraocular metal foreign bodies; patients with severe renal insufficiency (i.e. glomerular filtration rate as estimated by creatinine clearance < 30 mL/min at screening) due to increased risk of Nephrogenic Systemic Fibrosis following administration of gadolinium-based MRI contrast agents. Careful consideration should be given to patients with: metallic endoprosthesis, metal sutures and foreign bodies in other locations than the examined one, and claustrophobia.

Study & Design

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