CClinicalTrials.gg
Sign In
CompletedNCT02287922Updated Aug 21, 2019Results posted

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

A Phase 2 interventional study of ALX-0061 and Placebo in Rheumatoid Arthritis, sponsored by Ablynx, a Sanofi company. Completed at 83 sites in 14 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Ablynx, a Sanofi company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
251
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 251 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Ablynx, a Sanofi company is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
251 participants (actual)

Study arms

  • Experimental
    ALX-0061 150 mg q4w

    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.

    Biological: ALX-0061 · Biological: Placebo

  • Experimental
    ALX-0061 150 mg q2w

    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.

    Biological: ALX-0061 · Biological: Placebo

  • Experimental
    ALX-0061 225 mg q2w

    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.

    Biological: ALX-0061

  • Active comparator
    TCZ 162 mg q1w or q2w

    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).

    Biological: Tocilizumab

Interventions

  • BiologicalALX-0061
  • BiologicalPlacebo
  • BiologicalTocilizumab
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 12

Secondary outcomes

  1. 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.

    Time frame: Week 12

  2. 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.

    Time frame: Week 12

  3. 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.

    Time frame: Week 12

  4. 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.

    Time frame: Week 12

  5. 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.

    Time frame: Week 12

  6. 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.

    Time frame: Week 12

  7. 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.

    Time frame: Week 12

  8. 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.

    Time frame: Week 12

  9. 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.

    Time frame: Week 12

  10. 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.

    Time frame: Week 12

  11. 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.

    Time frame: From baseline until Week 12

  12. 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.

    Time frame: From baseline until week 12

  13. 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.

    Time frame: From baseline until Week 12

  14. Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)

    Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).

    Time frame: From baseline until Week 12

  15. Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12

    Time frame: From baseline until Week 12

  16. 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)

  17. Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity

    Time frame: From baseline until Week 12

  18. Number of Treatment-emergent Adverse Event by Severity

    Time frame: From baseline until Week 12

  19. 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

    Time frame: From baseline until Week 12

  20. Number of Treatment-related Treatment-emergent Adverse Event

    treatment related = considered at least possibly related to study drug by the Investigator

    Time frame: From baseline until Week 12

07

Results

Posted Aug 21, 2019

Participant flow

A total of 251 subjects were recruited at 58 sites located in Europe (42 sites; 199 subjects), Latin America (6 sites; 36 subjects) and North America (10 sites; 16 subjects). Consent was obtained from the first subject on 18 Mar 2015; the last subject completed the final visit in on 19 Jul 2016.

Participant flow — Overall Study
MilestoneALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Started62626364
Completed59605657
Not completed3277
Withdrew: Adverse event1134
Withdrew: Withdrawal by subject1112
Withdrew: Lost to follow-up0010
Withdrew: Sponsor's decision0001
Withdrew: Other1020

Outcome measures

PrimaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 1245485150
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
ACR5027233129
ACR7010151315
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
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
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
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 1226353828
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 1226323420
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 1223273322
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 1223213221
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 1225343828
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 1221132516
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects in Remission Using SDAI at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects in Remission Using SDAI at Week 125357
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects in Remission Using CDAI at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects in Remission Using CDAI at Week 126346
SecondaryNumber 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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 122344
SecondaryChange 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.

Time frame:
From baseline until Week 12
Reported as:
Mean · score on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
score on a scaleALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12-0.541 ± 0.0809-0.746 ± 0.0935-0.817 ± 0.0802-0.689 ± 0.0811
SecondaryChange 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.

Time frame:
From baseline until week 12
Reported as:
Mean · score on a scale
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12
score on a scaleALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
physical component7.808 ± 0.85337.979 ± 1.18958.861 ± 1.08187.611 ± 0.9562
mental component5.49 ± 1.2218.836 ± 1.52438.913 ± 1.39036.156 ± 1.3192
SecondaryChange 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.

Time frame:
From baseline until Week 12
Reported as:
Mean · score on a scale
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12
score on a scaleALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 127.832 ± 1.343811.41 ± 1.5312.996 ± 1.37028.971 ± 1.4461
SecondaryPharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)

Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).

Time frame:
From baseline until Week 12
Reported as:
Mean · ng/mL
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)
ng/mLALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Baseline33.0 ± 4.6542.3 ± 8.7130.9 ± 3.7231.0 ± 2.54
Week 12376 ± 21.6460 ± 19.9459 ± 18.8269 ± 11.1
SecondaryPharmacokinetics: ALX-0061 Concentration in Serum at Week 12
Time frame:
From baseline until Week 12
Reported as:
Geometric mean · micrograms/milliliter
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12
micrograms/milliliterALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2w
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 121.4 ± 3.6118.4 ± 2.9527.9 ± 2.53
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wALX-0061 Total
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response7252658
SecondaryNumber and Percentage of Subjects With Treatment-emergent Adverse Event by Severity
Time frame:
From baseline until Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Mild22182119
Moderate1213910
Severe0212
SecondaryNumber of Treatment-emergent Adverse Event by Severity
Time frame:
From baseline until Week 12
Reported as:
Number · Treatment-emergent adverse events
Number of Treatment-emergent Adverse Event by Severity
Treatment-emergent adverse eventsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Mild46758447
Moderate18221515
Severe0232
SecondaryNumber 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

Time frame:
From baseline until Week 12
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event
ParticipantsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event21202120
SecondaryNumber of Treatment-related Treatment-emergent Adverse Event

treatment related = considered at least possibly related to study drug by the Investigator

Time frame:
From baseline until Week 12
Reported as:
Number · treatment-emergent adverse events
Number of Treatment-related Treatment-emergent Adverse Event
treatment-emergent adverse eventsALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Number of Treatment-related Treatment-emergent Adverse Event46536432

Adverse events

Collected over From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ALX-0061 150 mg q4w0/62 (0%)1/62 (1.6%)15/62 (24.2%)
ALX-0061 150 mg q2w0/62 (0%)0/62 (0%)20/62 (32.3%)
ALX-0061 225 mg q2w0/63 (0%)2/63 (3.2%)17/63 (27%)
TCZ 162 mg q1w or q2w0/64 (0%)2/64 (3.1%)12/64 (18.8%)
Most frequent serious events
Most frequent serious events
EventALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/620/620/630/64
ErysipelasInfections and infestations0/620/621/630/64
DehydrationMetabolism and nutrition disorders0/620/621/630/64
DiverticulitisInfections and infestations0/620/620/631/64
Nail bed infection bacterialInfections and infestations0/620/620/631/64
Most frequent other events
Most frequent other events
EventALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2w
Injection site erythemaGeneral disorders4/627/625/632/64
HypercholesterolaemiaMetabolism and nutrition disorders2/625/627/632/64
NeutropeniaBlood and lymphatic system disorders4/623/620/635/64
LeukopeniaBlood and lymphatic system disorders4/621/620/632/64
Abdominal painGastrointestinal disorders0/624/621/630/64
Alanine aminotransferase increasedInfections and infestations1/620/624/631/64

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2wTotal
<=18 years01001
Between 18 and 65 years50535658217
>=65 years1287633
Age, Continuous
Age, Continuous(years)ALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2wTotal
Mean53.0 ± 12.2551.2 ± 12.0551.3 ± 11.8150.0 ± 12.2651.4 ± 12.07
Sex: Female, Male
Sex: Female, Male(Participants)ALX-0061 150 mg q4wALX-0061 150 mg q2wALX-0061 225 mg q2wTCZ 162 mg q1w or q2wTotal
Female49535456212
Male1399839
08

Study locations

83 sites
  • Investigator Site
    Birmingham, Alabama 35216, United States
  • Investigator Site
    Hemet, California 92543, United States
  • Investigator Site
    La Palma, California 90712, United States
  • Investigator site
    Los Angeles, California 90017, United States
  • Investigator Site
    Los Angeles, California 90036, United States
  • Investigator site
    Ventura, California 93003, United States
  • Investigator site
    Hialeah, Florida 33016, United States
  • Investigator Site
    Homestead, Florida 33030, United States
  • Investigator Site
    Orlando, Florida 32804, United States
  • Investigator Site
    Stockbridge, Georgia 30281, United States
  • Investigator site
    Overland Park, Kansas 66209, United States
  • Investigator Site
    Worcester, Massachusetts 01605, United States
  • Investigator Site
    Albuquerque, New Mexico 87102, United States
  • Investigator Site
    New York, New York 10018, United States
  • Investigator Site
    Charleston, South Carolina 29406, United States
  • Investigator Site
    Memphis, Tennessee 38119, United States
  • Investigator Site
    Mesquite, Texas 75150, United States
  • Investigator Site
    Brussels, 1200, Belgium
  • Investigator Site
    Ghent, 9000, Belgium
  • Investigator Site
    Liège, 4000, Belgium
  • Investigator Site
    Burgas, Bulgaria
  • Investigator Site
    Pleven, Bulgaria
  • Investigator Site 1
    Plovdiv, Bulgaria
  • Investigator Site 2
    Plovdiv, Bulgaria
  • Investigator Site 1
    Ruse, Bulgaria
  • Investigator Site 2
    Ruse, Bulgaria
  • Investigator Site
    Sofia, Bulgaria
  • Investigator Site
    Brno, 602000, Czechia
  • Investigator Site
    Olomouc, Czechia
  • Investigator Site
    Ostrava, 70300, Czechia
  • Investigator Site 1
    Prague, Czechia
  • Investigator Site 2
    Prague, Czechia
  • Investigator Site
    Zlin, Czechia
  • Investigator Site
    Tbilisi, 0102, Georgia
  • Investigator Site 1
    Tbilisi, 0159, Georgia
  • Investigator Site 2
    Tbilisi, 0159, Georgia
  • Investigator Site
    Tbilisi, 0160, Georgia
  • Investigator Site
    Tbilisi, 0179, Georgia
  • Investigator Site
    Berlin, Germany
  • Investigator Site
    Frankfurt, Germany
  • Investigator Site
    Hamburg, Germany
  • Investigator Site
    Baja, 6500, Hungary
  • Investigator Site
    Budapest, Hungary
  • Investigator Site
    Esztergom, Hungary
  • Investigator site
    Gyula, 5700, Hungary
  • Investigator Site
    Szikszo, 3800, Hungary
  • Investigator Site
    Szombathely, 9700, Hungary
  • Investigator Site
    Székesfehérvar, 8000, Hungary
  • Investigator Site
    Veszprém, 8200, Hungary
  • Investigator Site
    Culiacan, Mexico
  • Investigator Site
    Leon, Mexico
  • Investigator Site
    Mexico City 1, Mexico
  • Investigator Site 1
    Mexico City, Mexico
  • Investigator Site 2
    Mexico City, Mexico
  • Investigator Site 1
    Monterrey, Mexico
  • Investigator Site 2
    Monterrey, Mexico
  • Investigator Site
    Chisinau, 2025, Moldova, Republic of
  • Investigator Site
    Chisinau, Moldova, Republic of
  • Investigator Site 1
    Skopje, 1000, North Macedonia
  • Investigator Site 2
    Skopje, 1000, North Macedonia
  • Investigator Site
    Bydgoszcz, Poland
  • Investigator Site 2
    Elblag, 82300, Poland
  • Investigator Site
    Elblag, Poland
  • Investigator Site
    Gdynia, Poland
  • Investigator Site
    Grodzisk Mazowiecki, 05825, Poland
  • Investigator Site
    Lublin, 20582, Poland
  • Investigator SIte
    Poznan, 60773, Poland
  • Investigator Site
    Sochaczew, 96500, Poland
  • Investigator Site
    Torun, 87100, Poland
  • Investigator Site
    Warszawa, 02653, Poland
  • Investigator Site
    Bucharest, Romania
  • Investigator Site
    Oradea, Romania
  • Investigator Site
    Timisoara, Romania
  • Investigator Site 1
    Belgrade, Serbia
  • Investigator Site 2
    Belgrade, Serbia
  • Investigator Site 3
    Belgrade, Serbia
  • Investigator Site
    Niska Banja, Serbia
  • Investigator Site
    Cordoba, Spain
  • Investigator Site
    Madrid, 28007, Spain
  • Investigator Site
    Santander, 39300, Spain
  • Investigator Site 2
    Santander, Spain
  • Investigator Site 1
    Santiago de Compostela, Spain
  • Investigator Site 2
    Santiago de Compostela, Spain
09

References and documents

Study documents

  • Study protocol · Jul 9, 2015

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02287922
Lead sponsor
Ablynx, a Sanofi company
Responsible party
Sponsor
First posted
Nov 11, 2014
Start date
Mar 2015
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Aug 21, 2019
Last update
Aug 21, 2019

Study contacts

Medical Monitor, MD
study director · Ablynx, a Sanofi company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis→

Other studies from this sponsor

Ablynx, a Sanofi company

Start the discussion