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A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309359
Recruitment Status : Completed
First Posted : December 5, 2014
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: ALX-0061
Other: Placebo
Drug: Methotrexate
Enrollment 345
Recruitment Details A total of 345 subjects were recruited at 63 sites located in Europe (46 sites; 259 subjects), Latin America (7 sites; 59 subjects) and North America (10 sites; 27 subjects). Consent was obtained from the first subject on 30 Jan 2015; the last subject completed the final visit on 8 Aug 2016.
Pre-assignment Details Of the 712 subjects screened, 367 were screen failures and 345 were randomly assigned to treatment (Intent-to-treat population). All subjects enrolled received study drug and were included in the safety population. All subjects who received at least one dose of ALX-0061 (i.e., 276 subjects) were included in the pharmacokinetic (PK) population.
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + Methotrexate (MTX; at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Period Title: Overall Study
Started 69 70 68 69 69
Completed 57 62 57 57 60
Not Completed 12 8 11 12 9
Reason Not Completed
Adverse Event             4             5             5             4             4
Death             1             0             0             0             0
Withdrawal by Subject             2             2             4             4             0
Lack of Efficacy             3             1             0             0             3
Lost to Follow-up             0             0             0             1             0
Other             2             0             2             3             2
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX Total
Hide Arm/Group Description

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Total of all reporting groups
Overall Number of Baseline Participants 69 70 68 69 69 345
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 68 participants 69 participants 69 participants 345 participants
<=18 years
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Between 18 and 65 years
59
  85.5%
58
  82.9%
56
  82.4%
55
  79.7%
56
  81.2%
284
  82.3%
>=65 years
10
  14.5%
11
  15.7%
12
  17.6%
14
  20.3%
13
  18.8%
60
  17.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 70 participants 68 participants 69 participants 69 participants 345 participants
53.3  (10.35) 52  (13.16) 51.9  (11.93) 52.3  (13.36) 52.8  (11.92) 52.4  (12.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 68 participants 69 participants 69 participants 345 participants
Female
58
  84.1%
62
  88.6%
59
  86.8%
55
  79.7%
55
  79.7%
289
  83.8%
Male
11
  15.9%
8
  11.4%
9
  13.2%
14
  20.3%
14
  20.3%
56
  16.2%
1.Primary Outcome
Title Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
52
  75.4%
57
  81.4%
53
  77.9%
50
  72.5%
43
  62.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALX-0061 75 mg q4w + MTX, ALX-0061 150 mg q4w + MTX, ALX-0061 150 mg q2w + MTX, ALX-0061 225 mg q2w + MTX, Placebo q2w + MTX
Comments The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.
Type of Statistical Test Other
Comments Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
2.Secondary Outcome
Title Number and Percentage of Subjects With ACR20 Response at Week 24
Hide 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

This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 24 were treated as non responders.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
51
  73.9%
55
  78.6%
49
  72.1%
52
  75.4%
51
  73.9%
3.Secondary Outcome
Title Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24
Hide Description

ACR50 response is defined as:

  • 50% improvement in TJC (68 joints) relative to Week 0 AND
  • 50% improvement in SJC (66 joints) relative to Week 0 AND
  • 50% 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 the concerned visit were treated as non responders.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
20
  29.0%
31
  44.3%
28
  41.2%
31
  44.9%
19
  27.5%
Week 24
33
  47.8%
39
  55.7%
37
  54.4%
42
  60.9%
27
  39.1%
4.Secondary Outcome
Title Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24
Hide Description

ACR70 response is defined as:

  • 70% improvement in TJC (68 joints) relative to Week 0 AND
  • 70% improvement in SJC (66 joints) relative to Week 0 AND
  • 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 the concerned visit were treated as non responders.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
10
  14.5%
15
  21.4%
13
  19.1%
12
  17.4%
6
   8.7%
Week 24
16
  23.2%
23
  32.9%
15
  22.1%
31
  44.9%
12
  17.4%
5.Secondary Outcome
Title Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24
Hide 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

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
16
  23.2%
37
  52.9%
32
  47.1%
40
  58.0%
16
  23.2%
Week 24
26
  37.7%
40
  57.1%
41
  60.3%
48
  69.6%
20
  29.0%
6.Secondary Outcome
Title Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24
Hide 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
13
  18.8%
36
  51.4%
29
  42.6%
33
  47.8%
11
  15.9%
Week 24
24
  34.8%
38
  54.3%
33
  48.5%
46
  66.7%
13
  18.8%
7.Secondary Outcome
Title Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24
Hide Description

SDAI = TJC28 + SJC28 + Patient's Global Assessment of Disease Activity (VASPA) + Physician's Global Assessment of Disease Activity (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 NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
49
  71.0%
34
  48.6%
29
  42.6%
25
  36.2%
17
  24.6%
Week 24
29
  42.0%
34
  48.6%
35
  51.5%
46
  66.7%
22
  31.9%
8.Secondary Outcome
Title Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24
Hide 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
22
  31.9%
31
  44.3%
26
  38.2%
23
  33.3%
17
  24.6%
Week 24
29
  42.0%
33
  47.1%
29
  42.6%
43
  62.3%
23
  33.3%
9.Secondary Outcome
Title Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24
Hide 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
15
  21.7%
36
  51.4%
30
  44.1%
39
  56.5%
15
  21.7%
Week 24
26
  37.7%
39
  55.7%
39
  57.4%
47
  68.1%
19
  27.5%
10.Secondary Outcome
Title Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24
Hide 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
3
   4.3%
26
  37.1%
15
  22.1%
21
  30.4%
6
   8.7%
Week 24
17
  24.6%
26
  37.1%
23
  33.8%
37
  53.6%
8
  11.6%
11.Secondary Outcome
Title Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24
Hide 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
2
   2.9%
8
  11.4%
6
   8.8%
5
   7.2%
3
   4.3%
Week 24
7
  10.1%
13
  18.6%
10
  14.7%
14
  20.3%
6
   8.7%
12.Secondary Outcome
Title Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24
Hide 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
3
   4.3%
7
  10.0%
4
   5.9%
5
   7.2%
3
   4.3%
Week 24
10
  14.5%
13
  18.6%
8
  11.8%
13
  18.8%
7
  10.1%
13.Secondary Outcome
Title Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24
Hide 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 non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non responders.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12
0
   0.0%
5
   7.1%
2
   2.9%
4
   5.8%
3
   4.3%
Week 24
6
   8.7%
9
  12.9%
6
   8.8%
13
  18.8%
6
   8.7%
14.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24
Hide 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 till Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 -0.696  (0.0857) -0.619  (0.0657) -0.771  (0.0763) -0.615  (0.0858) -0.613  (0.0718)
Week 24 -0.82  (0.0913) -0.665  (0.0682) -0.876  (0.0802) -0.772  (0.0926) -0.662  (0.0798)
15.Secondary Outcome
Title Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24
Hide 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. The lower the score the more disability. The higher the score the less disability.
Time Frame from baseline till Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; "Number Analyzed" reflect the number of non-missing, non-imputed observations at that specific timepoint.
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 Number Analyzed 61 participants 66 participants 58 participants 60 participants 59 participants
7.372  (0.9136) 7.100  (0.7477) 6.534  (0.8878) 7.778  (0.994) 5.413  (0.7813)
Week 24 Number Analyzed 58 participants 62 participants 58 participants 58 participants 59 participants
10.412  (1.0642) 8.725  (0.9194) 8.835  (1.009) 10.762  (1.1497) 7.255  (0.9483)
16.Secondary Outcome
Title Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24
Hide 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. The lower the score the more disability. The higher the score the less disability.
Time Frame from baseline till Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; "Number Analyzed" reflect the number of non-missing, non-imputed observations at that specific timepoint.
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 Number Analyzed 61 participants 66 participants 58 participants 60 participants 60 participants
9.096  (1.4966) 7.249  (1.1237) 9.749  (1.4177) 5.686  (1.6485) 5.569  (1.6467)
Week 24 Number Analyzed 58 participants 62 participants 58 participants 58 participants 60 participants
9.857  (1.5326) 7.962  (1.3932) 11.739  (1.4159) 8.981  (1.6876) 6.198  (1.696)
17.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24
Hide 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 till Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; "Number Analyzed" reflect the number of non-missing, non-imputed observations at that specific timepoint.
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Mean (Standard Error)
Unit of Measure: score on a scale
Week 12 Number Analyzed 61 participants 65 participants 58 participants 61 participants 60 participants
11.014  (1.3593) 8.63  (1.0465) 10.884  (1.5424) 9.389  (1.3706) 6.381  (1.2026)
Week 24 Number Analyzed 58 participants 62 participants 58 participants 61 participants 62 participants
12.446  (1.5687) 10.439  (1.2157) 13.374  (1.5621) 12.381  (1.5193) 6.712  (1.4651)
18.Secondary Outcome
Title Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24
Hide Description ALX-0061 concentrations were only measured in samples of subjects randomized to any of the ALX-0061 treatment arms. Samples were taken predose at the concerned visits.
Time Frame at Week 12 and Week 24 visits
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69
Geometric Mean (Standard Deviation)
Unit of Measure: micrograms/milliliter
Week 12 0.163  (3.7) 1.79  (3.08) 19.9  (1.56) 32.1  (1.43)
Week 24 0.122  (2.56) 1.64  (3.11) 20.9  (1.5) 35.2  (1.37)
19.Secondary Outcome
Title Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24
Hide Description Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).
Time Frame from baseline till Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; "Number Analyzed" reflect the number of subjects with data available at that specific timepoint.
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Mean (Standard Error)
Unit of Measure: ng/mL
Baseline Number Analyzed 69 participants 70 participants 68 participants 69 participants 69 participants
26.9  (0.995) 29.2  (1.04) 27.7  (0.78) 28.9  (1.05) 28.9  (1.1)
Week 12 Number Analyzed 62 participants 66 participants 57 participants 61 participants 60 participants
166  (16.7) 420  (21) 519  (16.8) 488  (16.8) 52.9  (14.1)
Week 24 Number Analyzed 58 participants 61 participants 58 participants 59 participants 60 participants
150  (12.9) 422  (17.8) 484  (16.3) 487  (14.3) 35.4  (6.6)
20.Secondary Outcome
Title Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
Hide Description [Not Specified]
Time Frame from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX ALX-0061 Total
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

All participants who received ALX-0061
Overall Number of Participants Analyzed 69 70 68 69 69 276
Measure Type: Count of Participants
Unit of Measure: Participants
9
  13.0%
16
  22.9%
31
  45.6%
33
  47.8%
13
  18.8%
89
  32.2%
21.Secondary Outcome
Title Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity
Hide Description [Not Specified]
Time Frame From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
21
  30.4%
28
  40.0%
23
  33.8%
20
  29.0%
20
  29.0%
Moderate
15
  21.7%
12
  17.1%
19
  27.9%
20
  29.0%
14
  20.3%
Severe
6
   8.7%
4
   5.7%
2
   2.9%
4
   5.8%
2
   2.9%
22.Secondary Outcome
Title Number of Treatment-emergent Adverse Events by Severity
Hide Description [Not Specified]
Time Frame From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Number
Unit of Measure: Adverse events
Mild 66 78 66 56 49
Moderate 34 24 26 40 22
Severe 6 5 4 5 2
23.Secondary Outcome
Title Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
26
  37.7%
25
  35.7%
26
  38.2%
25
  36.2%
18
  26.1%
24.Secondary Outcome
Title Number of Treatment-related Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description:

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Overall Number of Participants Analyzed 69 70 68 69 69
Measure Type: Number
Unit of Measure: Adverse events
55 52 46 47 21
Time Frame From first study drug intake up to and including follow-up, i.e., maximum of 34 weeks (22 weeks of treatment + 12 weeks of follow-up).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Hide Arm/Group Description

ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

ALX-0061

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.

ALX-0061

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.

Placebo

Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).

All-Cause Mortality
ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/69 (1.45%)      0/70 (0.00%)      0/68 (0.00%)      0/69 (0.00%)      0/69 (0.00%)    
Hide Serious Adverse Events
ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/69 (7.25%)      5/70 (7.14%)      0/68 (0.00%)      2/69 (2.90%)      4/69 (5.80%)    
Blood and lymphatic system disorders           
Cytopenia  1  0/69 (0.00%)  0 1/70 (1.43%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Cardiac disorders           
Cardiac arrest  1  1/69 (1.45%)  1 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Gastrointestinal disorders           
Gastritis  1  1/69 (1.45%)  1 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Large intestine perforation  1  0/69 (0.00%)  0 0/70 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/69 (0.00%)  0
Infections and infestations           
Arthritis bacterial  1  0/69 (0.00%)  0 0/70 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/69 (0.00%)  0
Cellulitis  1  0/69 (0.00%)  0 1/70 (1.43%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Ear infection  1  1/69 (1.45%)  1 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Herpes Zoster  1  0/69 (0.00%)  0 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 1/69 (1.45%)  1
Pneumonia  1  0/69 (0.00%)  0 2/70 (2.86%)  2 0/68 (0.00%)  0 0/69 (0.00%)  0 1/69 (1.45%)  1
Sepsis  1  0/69 (0.00%)  0 1/70 (1.43%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Pharyngitis  1  0/69 (0.00%)  0 1/70 (1.43%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Staphylococcal sepsis  1  0/69 (0.00%)  0 0/70 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/69 (0.00%)  0
Intervertebral discitis  1  0/69 (0.00%)  0 0/70 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/69 (0.00%)  0
Injury, poisoning and procedural complications           
Tendon rupture  1  0/69 (0.00%)  0 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 2/69 (2.90%)  2
Musculoskeletal and connective tissue disorders           
Rheumatoid arthritis  1  0/69 (0.00%)  0 1/70 (1.43%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Ovarian adenoma  1  1/69 (1.45%)  1 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
Skin and subcutaneous tissue disorders           
Angioedema  1  1/69 (1.45%)  1 0/70 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALX-0061 75 mg q4w + MTX ALX-0061 150 mg q4w + MTX ALX-0061 150 mg q2w + MTX ALX-0061 225 mg q2w + MTX Placebo q2w + MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/69 (42.03%)      34/70 (48.57%)      27/68 (39.71%)      38/69 (55.07%)      17/69 (24.64%)    
Blood and lymphatic system disorders           
Neutropenia  1  4/69 (5.80%)  7 2/70 (2.86%)  2 0/68 (0.00%)  0 0/69 (0.00%)  0 0/69 (0.00%)  0
General disorders           
Injection site erythema  1  4/69 (5.80%)  5 5/70 (7.14%)  7 7/68 (10.29%)  8 3/69 (4.35%)  3 0/69 (0.00%)  0
Infections and infestations           
Bronchitis  1  6/69 (8.70%)  7 2/70 (2.86%)  2 3/68 (4.41%)  3 3/69 (4.35%)  3 3/69 (4.35%)  3
Nasopharyngitis  1  4/69 (5.80%)  4 5/70 (7.14%)  5 2/68 (2.94%)  2 4/69 (5.80%)  4 6/69 (8.70%)  6
Pharyngitis  1  2/69 (2.90%)  2 6/70 (8.57%)  6 3/68 (4.41%)  4 1/69 (1.45%)  1 0/69 (0.00%)  0
Upper respiratory tract infection  1  0/69 (0.00%)  0 1/70 (1.43%)  1 2/68 (2.94%)  2 7/69 (10.14%)  7 3/69 (4.35%)  3
Investigations           
Alanine aminotransferase increased  1  2/69 (2.90%)  3 2/70 (2.86%)  2 2/68 (2.94%)  2 6/69 (8.70%)  7 0/69 (0.00%)  0
Aspartate aminotransferase increased  1  2/69 (2.90%)  2 2/70 (2.86%)  2 1/68 (1.47%)  1 5/69 (7.25%)  6 0/69 (0.00%)  0
Metabolism and nutrition disorders           
Hypercholesterolaemia  1  2/69 (2.90%)  2 7/70 (10.00%)  7 4/68 (5.88%)  6 5/69 (7.25%)  6 4/69 (5.80%)  4
Vascular disorders           
Hypertension  1  3/69 (4.35%)  3 2/70 (2.86%)  2 3/68 (4.41%)  3 4/69 (5.80%)  5 1/69 (1.45%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of any results from this study will be according to the principles of the Declaration of Helsinki, and will require prior review and written agreement of the Sponsor.
Results Point of Contact
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Name/Title: Medical Monitor
Organization: Ablynx NV
Phone: +32 (0)9 262 00 00
EMail: clinicaltrials@ablynx.com
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Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02309359    
Other Study ID Numbers: ALX0061-C201
2014-003033-26 ( EudraCT Number )
First Submitted: November 27, 2014
First Posted: December 5, 2014
Results First Submitted: June 12, 2019
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019