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A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALX-0061
Placebo
Tocilizumab
Sponsored by
Ablynx, a Sanofi company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
  • Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
  • Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
  • Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
  • Others as defined in the protocol

Exclusion Criteria:

  • Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
  • Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.
  • Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA.
  • Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
  • Others as defined in the protocol.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

ALX-0061 150 mg q4w

ALX-0061 150 mg q2w

ALX-0061 225 mg q2w

TCZ 162 mg q1w or q2w

Arm Description

ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.

ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.

ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.

Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).

Outcomes

Primary Outcome Measures

Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12
ACR 20 response is defined as: 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND 20% improvement in 3 of the following 5 areas relative to Week 0: Subject's Assessment of Pain (100 mm - visual analogue scale [VAS]) Subject's Global Assessment of Disease Activity (VASPA) Physician's Global Assessment of Disease Activity (VASPHA) Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.

Secondary Outcome Measures

Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12
ACR50/70 response is defined as: 50/70% improvement in TJC (68 joints) relative to Week 0 AND 50/70% improvement in SJC (66 joints) relative to Week 0 AND 50/70% improvement in 3 of the following 5 areas relative to Week 0: Subject's Assessment of Pain (100 mm - VAS) Subject's Global Assessment of Disease Activity (VASPA) Physician's Global Assessment of Disease Activity (VASPHA) Subject's assessment of physical function as measured by HAQ-DI CRP level This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 12 were treated as non-responders.
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12
DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96 Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA) Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12
SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL) Low disease activity: 3.3 < SDAI ≤ 11.0 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12
CDAI = TJC28 + SJC28 + VASPA + VASPHA Low disease activity: 2.8 < CDAI ≤ 10 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12
EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA) Remission = DAS28(ESR) < 2.6 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects in Remission Using SDAI at Week 12
SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL) Remission: SDAI ≤ 3.3 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects in Remission Using CDAI at Week 12
CDAI = TJC28 + SJC28 + VASPA + VASPHA Remission: CDAI ≤ 2.8 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12
Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome). Missing values were imputed with the last non-missing observation.
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12
The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Low score indicates greater disability.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12
The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)
Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity
Number of Treatment-emergent Adverse Event by Severity
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event
treatment related = considered at least possibly related to study drug by the Investigator
Number of Treatment-related Treatment-emergent Adverse Event
treatment related = considered at least possibly related to study drug by the Investigator

Full Information

First Posted
November 5, 2014
Last Updated
August 6, 2019
Sponsor
Ablynx, a Sanofi company
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1. Study Identification

Unique Protocol Identification Number
NCT02287922
Brief Title
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Official Title
A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablynx, a Sanofi company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is: - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development. To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALX-0061 150 mg q4w
Arm Type
Experimental
Arm Description
ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
Arm Title
ALX-0061 150 mg q2w
Arm Type
Experimental
Arm Description
ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
Arm Title
ALX-0061 225 mg q2w
Arm Type
Experimental
Arm Description
ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
Arm Title
TCZ 162 mg q1w or q2w
Arm Type
Active Comparator
Arm Description
Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).
Intervention Type
Biological
Intervention Name(s)
ALX-0061
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Type
Biological
Intervention Name(s)
Tocilizumab
Primary Outcome Measure Information:
Title
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12
Description
ACR 20 response is defined as: 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND 20% improvement in 3 of the following 5 areas relative to Week 0: Subject's Assessment of Pain (100 mm - visual analogue scale [VAS]) Subject's Global Assessment of Disease Activity (VASPA) Physician's Global Assessment of Disease Activity (VASPHA) Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12
Description
ACR50/70 response is defined as: 50/70% improvement in TJC (68 joints) relative to Week 0 AND 50/70% improvement in SJC (66 joints) relative to Week 0 AND 50/70% improvement in 3 of the following 5 areas relative to Week 0: Subject's Assessment of Pain (100 mm - VAS) Subject's Global Assessment of Disease Activity (VASPA) Physician's Global Assessment of Disease Activity (VASPHA) Subject's assessment of physical function as measured by HAQ-DI CRP level This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 12 were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12
Description
DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96 Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12
Description
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA) Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12
Description
SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL) Low disease activity: 3.3 < SDAI ≤ 11.0 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12
Description
CDAI = TJC28 + SJC28 + VASPA + VASPHA Low disease activity: 2.8 < CDAI ≤ 10 Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12
Description
EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12
Description
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA) Remission = DAS28(ESR) < 2.6 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects in Remission Using SDAI at Week 12
Description
SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL) Remission: SDAI ≤ 3.3 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects in Remission Using CDAI at Week 12
Description
CDAI = TJC28 + SJC28 + VASPA + VASPHA Remission: CDAI ≤ 2.8 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12
Description
Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Time Frame
Week 12
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Description
The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome). Missing values were imputed with the last non-missing observation.
Time Frame
From baseline until Week 12
Title
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12
Description
The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Low score indicates greater disability.
Time Frame
From baseline until week 12
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12
Description
The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame
From baseline until Week 12
Title
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)
Description
Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).
Time Frame
From baseline until Week 12
Title
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12
Time Frame
From baseline until Week 12
Title
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
Time Frame
From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU)
Title
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity
Time Frame
From baseline until Week 12
Title
Number of Treatment-emergent Adverse Event by Severity
Time Frame
From baseline until Week 12
Title
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event
Description
treatment related = considered at least possibly related to study drug by the Investigator
Time Frame
From baseline until Week 12
Title
Number of Treatment-related Treatment-emergent Adverse Event
Description
treatment related = considered at least possibly related to study drug by the Investigator
Time Frame
From baseline until Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III. Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use. Subjects must not have received MTX for at least 4 weeks before first administration of the study drug. Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline Others as defined in the protocol Exclusion Criteria: Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug. Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening. Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA. Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time. Others as defined in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Ablynx, a Sanofi company
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Investigator Site
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Investigator Site
City
La Palma
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Investigator site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Investigator Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Investigator site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Investigator site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Investigator Site
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Investigator Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigator Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Investigator site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Investigator Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Investigator Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Investigator Site
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Investigator Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigator Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigator Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Investigator Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigator Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigator Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigator Site
City
Burgas
Country
Bulgaria
Facility Name
Investigator Site
City
Pleven
Country
Bulgaria
Facility Name
Investigator Site 1
City
Plovdiv
Country
Bulgaria
Facility Name
Investigator Site 2
City
Plovdiv
Country
Bulgaria
Facility Name
Investigator Site 1
City
Ruse
Country
Bulgaria
Facility Name
Investigator Site 2
City
Ruse
Country
Bulgaria
Facility Name
Investigator Site
City
Sofia
Country
Bulgaria
Facility Name
Investigator Site
City
Brno
ZIP/Postal Code
602000
Country
Czechia
Facility Name
Investigator Site
City
Olomouc
Country
Czechia
Facility Name
Investigator Site
City
Ostrava
ZIP/Postal Code
70300
Country
Czechia
Facility Name
Investigator Site 1
City
Prague
Country
Czechia
Facility Name
Investigator Site 2
City
Prague
Country
Czechia
Facility Name
Investigator Site
City
Zlin
Country
Czechia
Facility Name
Investigator Site
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Investigator Site 1
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site 2
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigator Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Investigator Site
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Investigator Site
City
Berlin
Country
Germany
Facility Name
Investigator Site
City
Frankfurt
Country
Germany
Facility Name
Investigator Site
City
Hamburg
Country
Germany
Facility Name
Investigator Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Investigator Site
City
Budapest
Country
Hungary
Facility Name
Investigator Site
City
Esztergom
Country
Hungary
Facility Name
Investigator site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Investigator Site
City
Szikszo
ZIP/Postal Code
3800
Country
Hungary
Facility Name
Investigator Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Investigator Site
City
Székesfehérvar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Investigator Site
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Investigator Site
City
Culiacan
Country
Mexico
Facility Name
Investigator Site
City
Leon
Country
Mexico
Facility Name
Investigator Site
City
Mexico City 1
Country
Mexico
Facility Name
Investigator Site 1
City
Mexico City
Country
Mexico
Facility Name
Investigator Site 2
City
Mexico City
Country
Mexico
Facility Name
Investigator Site 1
City
Monterrey
Country
Mexico
Facility Name
Investigator Site 2
City
Monterrey
Country
Mexico
Facility Name
Investigator Site
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Investigator Site
City
Chisinau
Country
Moldova, Republic of
Facility Name
Investigator Site 1
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Investigator Site 2
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Investigator Site
City
Bydgoszcz
Country
Poland
Facility Name
Investigator Site 2
City
Elblag
ZIP/Postal Code
82300
Country
Poland
Facility Name
Investigator Site
City
Elblag
Country
Poland
Facility Name
Investigator Site
City
Gdynia
Country
Poland
Facility Name
Investigator Site
City
Grodzisk Mazowiecki
ZIP/Postal Code
05825
Country
Poland
Facility Name
Investigator Site
City
Lublin
ZIP/Postal Code
20582
Country
Poland
Facility Name
Investigator SIte
City
Poznan
ZIP/Postal Code
60773
Country
Poland
Facility Name
Investigator Site
City
Sochaczew
ZIP/Postal Code
96500
Country
Poland
Facility Name
Investigator Site
City
Torun
ZIP/Postal Code
87100
Country
Poland
Facility Name
Investigator Site
City
Warszawa
ZIP/Postal Code
02653
Country
Poland
Facility Name
Investigator Site
City
Bucharest
Country
Romania
Facility Name
Investigator Site
City
Oradea
Country
Romania
Facility Name
Investigator Site
City
Timisoara
Country
Romania
Facility Name
Investigator Site 1
City
Belgrade
Country
Serbia
Facility Name
Investigator Site 2
City
Belgrade
Country
Serbia
Facility Name
Investigator Site 3
City
Belgrade
Country
Serbia
Facility Name
Investigator Site
City
Niska Banja
Country
Serbia
Facility Name
Investigator Site
City
Cordoba
Country
Spain
Facility Name
Investigator Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigator Site
City
Santander
ZIP/Postal Code
39300
Country
Spain
Facility Name
Investigator Site 2
City
Santander
Country
Spain
Facility Name
Investigator Site 1
City
Santiago de Compostela
Country
Spain
Facility Name
Investigator Site 2
City
Santiago de Compostela
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

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