A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 6 November 2017
• Main ID: EUCTR2014-003033-26-CZ
• Date of registration: 05/12/2014
• Prospective Registration: Yes
• Primary sponsor: Ablynx NV
• Public title: A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis
• Scientific title: A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
• Date of first enrolment: 08/07/2015
• Target sample size: 330
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003033-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, Bulgaria, Czech Republic, Georgia, Germany, Hungary, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Poland, Romania, Serbia, Spain, United States

Contacts

• Name: Regulatory Affairs Lead
• Affiliation: Worldwide Clinical Trials Ltd

• Name: Regulatory Affairs Lead
• Affiliation: Worldwide Clinical Trials Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
The main criteria for inclusion include the following:
• Man or woman = 18 years and < 75 years of age at the time of signing the informed consent form.
• Diagnosis of RA for at least 6 months prior to screening, and ACR functional class I-III.
• Treated with and tolerating MTX
• Active RA

A complete list of selection criteria can be found in the body of the Clinical Study Protocol
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 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion criteria:
The main criteria for exclusion include the following:
• Have been treated with DMARDs/systemic immunosuppressives other than MTX.
• Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
• For subjects who received prior rituximab, subjects with an inadequate recovery of B cells should be excluded regardless of when they received
rituximab.
• Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs for RA.
• Have received prior therapy blocking the interleukin-6 (IL-6) pathway at any time.

A complete list of selection criteria can be found in the body of the Clinical Study Protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Rheumatoid Arthritis (RA)
MedDRA version: 18.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders

Intervention(s)

Product Name: ALX-0061
Product Code: ALX-0061
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
Other descriptive name: ALX-0061
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Reduction of signs and symptoms of RA

Main Objective: •To assess the efficacy and safety of dose regimens of ALX-0061 administered s.c. in combination with MTX to subjects with active RA despite MTX therapy compared with placebo.

Secondary Objective: •To assess the effects of ALX-0061 on quality of life, PK, PD, and immunogenicity of ALX 0061, and to define the optimal dose regimen for ALX 0061, based on safety and efficacy, for further clinical development.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 24 weeks evaluation for secondary endopoints mentioned bove (first 7 bullet points)

PK: 24 weeks

PD, safety and immunogenicity: For the complete duration of the study

Secondary end point(s): - ACR20, ACR50, and ACR70 response over time.
- Disease activity: Disease Activity Score using 28 joint counts (DAS28 using CRP and erythrocyte sedimentation rate [ESR]), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI).
- EULAR DAS28 response (good, moderate, or no response).
- Remission using disease remission parameters: DAS28, SDAI, CDAI, Boolean.
- Health Assessment Questionnaire-Disability Index (HAQ-DI).
- Physical and mental component scores of Short Form Health Survey (SF-36).
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue).

- Pharmacokinetics

- Pharmacodynamics

- Safety

- Immunogenicity

Secondary ID(s)

2014-003033-26-BE

ALX0061-C201

Source(s) of Monetary Support

Ablynx NV