Trial Outcomes & Findings for Prospective Evaluation of the Radiographic Efficacy of Enbrel (NCT NCT01623752)

Last Updated: 2019-08-16

Results Overview

To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.

Recruitment status

COMPLETED

Target enrollment

1821 participants

Primary outcome timeframe

Baseline, Week 78

Results posted on

2019-08-16

Participant Flow

Participants those who were recruited despite of an unknown or unclear disease diagnosis, were only included in safety analysis for the study, not for efficacy evaluation.

Participant milestones

Participant milestones
Measure	Participants With Rheumatoid Arthritis Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Phase 1 (78 Weeks) STARTED	1378	440	3
Phase 1 (78 Weeks) COMPLETED	747	233	1
Phase 1 (78 Weeks) NOT COMPLETED	631	207	2
Phase 2 (78 Weeks) STARTED	291	116	0
Phase 2 (78 Weeks) COMPLETED	225	98	0
Phase 2 (78 Weeks) NOT COMPLETED	66	18	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Rheumatoid Arthritis Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Phase 1 (78 Weeks) No Data	249	66	2
Phase 1 (78 Weeks) Other	33	20	0
Phase 1 (78 Weeks) Adverse Event	122	39	0
Phase 1 (78 Weeks) Lack of Efficacy	227	82	0
Phase 2 (78 Weeks) Lack of Efficacy	14	2	0
Phase 2 (78 Weeks) Other	5	1	0
Phase 2 (78 Weeks) No Data	43	11	0
Phase 2 (78 Weeks) Adverse Event	4	4	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Rheumatoid Arthritis n=1378 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=440 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis n=3 Participants Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Total n=1821 Participants Total of all reporting groups
Age, Customized Less than 18 years	1 Participants n=1378 Participants	0 Participants n=440 Participants	0 Participants n=3 Participants	1 Participants n=1821 Participants
Age, Customized 18 to 64 years	976 Participants n=1378 Participants	387 Participants n=440 Participants	2 Participants n=3 Participants	1365 Participants n=1821 Participants
Age, Customized 65 years or more	395 Participants n=1378 Participants	49 Participants n=440 Participants	0 Participants n=3 Participants	444 Participants n=1821 Participants
Age, Customized No data	6 Participants n=1378 Participants	4 Participants n=440 Participants	1 Participants n=3 Participants	11 Participants n=1821 Participants
Sex/Gender, Customized Female	1062 Participants n=1378 Participants	259 Participants n=440 Participants	2 Participants n=3 Participants	1323 Participants n=1821 Participants
Sex/Gender, Customized Male	316 Participants n=1378 Participants	181 Participants n=440 Participants	0 Participants n=3 Participants	497 Participants n=1821 Participants
Sex/Gender, Customized No Data	0 Participants n=1378 Participants	0 Participants n=440 Participants	1 Participants n=3 Participants	1 Participants n=1821 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline, Week 78

Population: Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, "Overall Number of Participants Analyzed" =number of participants evaluable for this outcome measure; "Number Analyzed"=number of participants evaluable for the specified time points.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=504 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=166 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) Baseline	25.1 Units on a scale Standard Deviation 42.4	14.7 Units on a scale Standard Deviation 25.7	—
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) Change at Week 78	0.6 Units on a scale Standard Deviation 7.2	-0.4 Units on a scale Standard Deviation 5.9	—

PRIMARY outcome

Timeframe: Baseline, Week 78

Population: Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. "Number Analyzed"= participants evaluable for the specified time points.

To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=500 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=164 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) Baseline	25.3 Units on a scale Standard Deviation 42.5	14.7 Units on a scale Standard Deviation 25.8	—
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) Change at Week 78	0.6 Units on a scale Standard Deviation 7.2	-0.5 Units on a scale Standard Deviation 5.8	—

PRIMARY outcome

Timeframe: Baseline, Week 156

Population: Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=97 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=48 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS	1.4 Units on a scale Standard Deviation 9.9	0.7 Units on a scale Standard Deviation 8.2	—

PRIMARY outcome

Timeframe: Baseline, Week 156

Population: Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=96 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=48 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS	1.4 Units on a scale Standard Deviation 9.9	0.7 Units on a scale Standard Deviation 8.2	—

PRIMARY outcome

Timeframe: Pre-treatment, Week 78

Population: Efficacy analysis set for Phase 1 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points.

The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than \[\>\] 0.5), no change (-0.5 to 0.5) and decrease (less than \[\<\] -0.5). Participants with no change or a decrease were considered to be in radiographic remission.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=189 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=46 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS Pre-treatment	0.959 Scores per year Standard Deviation 4.396	1.056 Scores per year Standard Deviation 5.127	—
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS Change at Week 78	-0.267 Scores per year Standard Deviation 5.989	-0.995 Scores per year Standard Deviation 8.628	—

PRIMARY outcome

Timeframe: Pre-treatment, Week 78

Population: CAS for phase 1 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and provided data for end of Phase 1 of study. Here, "Overall Number of Participants Analyzed"=number of participants evaluable for this outcome measure and "Number Analyzed"=number of participants evaluable for the specified time points.

The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=187 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=45 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS Pre-treatment	0.981 Scores per year Standard Deviation 4.413	1.080 Scores per year Standard Deviation 5.182	—
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS Change at Week 78	-0.306 Scores per year Standard Deviation 6.002	-1.033 Scores per year Standard Deviation 8.724	—

PRIMARY outcome

Timeframe: Pre-treatment, Week 156

Population: Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx3. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=40 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=15 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS	-0.473 Scores per year Standard Deviation 5.940	-0.348 Scores per year Standard Deviation 3.985	—

PRIMARY outcome

Timeframe: Pre-treatment, Week 156

Population: CAS for phase 2 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and completed phase 2 of the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=40 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=15 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS	-0.473 Scores per year Standard Deviation 5.940	-0.348 Scores per year Standard Deviation 3.985	—

SECONDARY outcome

Timeframe: Baseline up to Week 78

Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=466 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=157 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Linear Relationship Between Normalized Radiographic Progression and Disease Duration	-0.012 Regression coefficient	-0.050 Regression coefficient	—

SECONDARY outcome

Timeframe: Baseline up to Week 78

Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows.

Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=387 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=87 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) ACPA and RF negative	1.326 Scores per year Interval 0.292 to 2.359	-1.142 Scores per year Interval -2.486 to 0.202	—
Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) ACPA or RF positive	1.075 Scores per year Interval 0.072 to 2.078	2.448 Scores per year Interval -2.398 to 7.294	—
Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) ACPA and RF positive	0.087 Scores per year Interval -0.665 to 0.839	3.370 Scores per year Interval -3.484 to 10.224	—

SECONDARY outcome

Timeframe: Baseline up to Week 78

Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows.

Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=471 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=157 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication Concomitant Medication at baseline: Yes	0.749 Scores per year Interval 0.253 to 1.245	-0.339 Scores per year Interval -1.339 to 0.661	—
Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication Concomitant Medication at baseline: No	-0.978 Scores per year Interval -2.276 to 0.32	-0.370 Scores per year Interval -1.592 to 0.851	—

SECONDARY outcome

Timeframe: Baseline up to Week 78

Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows.

Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=471 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=157 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics Previous treatment with biologics	0.235 Scores per year Interval -0.72 to 1.191	-0.986 Scores per year Interval -2.621 to 0.649	—
Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics No previous treatment with biologics	0.621 Scores per year Interval 0.087 to 1.155	-0.170 Scores per year Interval -1.045 to 0.706	—

SECONDARY outcome

Timeframe: Baseline up to Week 78

Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified rows.

Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (\<=) 5.1 or \>5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity \>5.1. DAS28 score of \<2.6 indicates disease remission.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=367 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=126 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) Baseline DAS-28 <= 5.1	0.716 Scores per year Interval 0.033 to 1.399	-0.314 Scores per year Interval -1.242 to 0.613	—
Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) Baseline DAS-28 > 5.1	0.170 Scores per year Interval -0.792 to 1.133	-0.507 Scores per year Interval -2.283 to 1.268	—

SECONDARY outcome

Timeframe: Baseline, Week 78, 156

Population: Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or had Rx1 and Rx3. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points.

Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 \[no erosion\] to 5 \[maximum severity\], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 10 \[maximum severity\], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction.

Outcome measures

Outcome measures
Measure	Participants With Rheumatoid Arthritis n=505 Participants Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Psoriatic Arthritis n=166 Participants Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.	Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156.
Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) Baseline	11.1 Units on a scale Standard Deviation 23.8	4.6 Units on a scale Standard Deviation 11.9	—
Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) Change at Week 78	-0.1 Units on a scale Standard Deviation 4.1	-0.3 Units on a scale Standard Deviation 3.1	—
Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) Change at Week 156	0.0 Units on a scale Standard Deviation 5.7	0.2 Units on a scale Standard Deviation 6.5	—

SECONDARY outcome

Timeframe: Baseline, Week 78, 156

Population: Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or have Rx1 and Rx3. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for the specified time points.

Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 \[normal joint space\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction.